Trial Outcomes & Findings for Health Evaluation in African Americans Using RAS Therapy (NCT NCT02471833)
NCT ID: NCT02471833
Last Updated: 2024-05-23
Results Overview
The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 1 helps to regulate blood pressure by converting angiotensin I to angiotensin II.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline, Month 8
Results posted on
2024-05-23
Participant Flow
Participants were recruited from the Wesley Woods Health Center, Emory Alzheimer's Clinical Research Unit (ACRU), and the Emory Brain Health Center in Atlanta, Georgia, USA. Participant enrollment began April 2015 and all follow-up assessments were completed by April 15, 2022.
Participant milestones
| Measure |
Telmisartan 20mg
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease (AD) who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
24
|
|
Overall Study
Completed 8 Months of Study Treatment
|
12
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
5
|
Reasons for withdrawal
| Measure |
Telmisartan 20mg
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease (AD) who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
5
|
Baseline Characteristics
Health Evaluation in African Americans Using RAS Therapy
Baseline characteristics by cohort
| Measure |
Telmisartan 20mg
n=19 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=18 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=24 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.79 years
STANDARD_DEVIATION 8.85 • n=5 Participants
|
60.44 years
STANDARD_DEVIATION 7.48 • n=7 Participants
|
60.54 years
STANDARD_DEVIATION 8.65 • n=5 Participants
|
59.66 years
STANDARD_DEVIATION 8.48 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19. Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 1 helps to regulate blood pressure by converting angiotensin I to angiotensin II.
Outcome measures
| Measure |
Telmisartan 20mg
n=10 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=15 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Concentration of Angiotensin Converting Enzyme (ACE 1)
Baseline
|
4043.15 ng/mL
Standard Deviation 1425.34
|
4028.17 ng/mL
Standard Deviation 1509.02
|
3836.31 ng/mL
Standard Deviation 1627.50
|
|
Concentration of Angiotensin Converting Enzyme (ACE 1)
Month 8
|
3305.21 ng/mL
Standard Deviation 764.54
|
4102.96 ng/mL
Standard Deviation 1498.07
|
3696.71 ng/mL
Standard Deviation 1309.61
|
PRIMARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
The cerebrospinal fluid renin-angiotensin system (RAS) was assessed by measuring levels of angiotensin metabolites in a 1 milliliter (mL) sample of cerebrospinal fluid (CSF). ACE 2 regulates levels of circulating angiotensin II. ACE 2 increases during illness and with Alzheimer's disease.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=14 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Concentration of Angiotensin Converting Enzyme 2 (ACE 2)
Baseline
|
889.06 ng/mL
Standard Deviation 870.83
|
566.43 ng/mL
Standard Deviation 700.13
|
783.72 ng/mL
Standard Deviation 998.95
|
|
Concentration of Angiotensin Converting Enzyme 2 (ACE 2)
Month 8
|
231.86 ng/mL
Standard Deviation 47.66
|
274.17 ng/mL
Standard Deviation 84.74
|
264.83 ng/mL
Standard Deviation 109.40
|
PRIMARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Levels of amyloid β40 (Aβ40) in the cerebrospinal fluid were measured using LUMIPULSE® technology. The relationship between Aβ40 is non-linear with moderate levels showing the highest risk of future cognitive decline in some studies.
Outcome measures
| Measure |
Telmisartan 20mg
n=11 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Cerebrospinal Fluid Amyloid β40
Baseline
|
7704.82 picograms per milliliter (pg/mL)
Standard Deviation 2237.94
|
9121.62 picograms per milliliter (pg/mL)
Standard Deviation 3174.21
|
8259.13 picograms per milliliter (pg/mL)
Standard Deviation 2176.62
|
|
Cerebrospinal Fluid Amyloid β40
Month 8
|
8011.44 picograms per milliliter (pg/mL)
Standard Deviation 2688.34
|
8820.08 picograms per milliliter (pg/mL)
Standard Deviation 2514.47
|
8300.67 picograms per milliliter (pg/mL)
Standard Deviation 2623.31
|
PRIMARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Levels of amyloid β42 (Aβ42) in the cerebrospinal fluid were measured using LUMIPULSE® technology. Decreases in concentrations of amyloid β42 are indicative of a decrease in cognitive function.
Outcome measures
| Measure |
Telmisartan 20mg
n=11 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Levels of Cerebrospinal Fluid Amyloid β42
Baseline
|
611.91 pg/mL
Standard Deviation 138.51
|
614.54 pg/mL
Standard Deviation 193.54
|
578.31 pg/mL
Standard Deviation 190.75
|
|
Levels of Cerebrospinal Fluid Amyloid β42
Month 8
|
620.89 pg/mL
Standard Deviation 256.43
|
665.42 pg/mL
Standard Deviation 278.00
|
599.25 pg/mL
Standard Deviation 204.17
|
PRIMARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Levels of T-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of T-tau are indicative of a decrease in cognitive function.
Outcome measures
| Measure |
Telmisartan 20mg
n=11 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Levels of Cerebrospinal Fluid T-tau
Baseline
|
347.73 pg/mL
Standard Deviation 371.85
|
281.23 pg/mL
Standard Deviation 89.72
|
248.94 pg/mL
Standard Deviation 107.67
|
|
Levels of Cerebrospinal Fluid T-tau
Month 8
|
393.11 pg/mL
Standard Deviation 404.35
|
266.58 pg/mL
Standard Deviation 83.23
|
244.58 pg/mL
Standard Deviation 67.04
|
PRIMARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Levels of P-tau in the cerebrospinal fluid were measured using LUMIPULSE® technology. Increases in concentrations of P-tau are indicative of a decrease in cognitive function.
Outcome measures
| Measure |
Telmisartan 20mg
n=11 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Levels of Cerebrospinal Fluid P-tau
Baseline
|
29.75 pg/mL
Standard Deviation 12.88
|
36.55 pg/mL
Standard Deviation 11.24
|
31.58 pg/mL
Standard Deviation 13.24
|
|
Levels of Cerebrospinal Fluid P-tau
Month 8
|
30.48 pg/mL
Standard Deviation 10.16
|
35.68 pg/mL
Standard Deviation 13.67
|
30.48 pg/mL
Standard Deviation 10.30
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
The inflammatory marker IL-6 in CSF was examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=8 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=12 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Interleukin-6 (IL-6) Frequency
Baseline
|
9.41 pg/mL
Standard Deviation 3.25
|
10.65 pg/mL
Standard Deviation 6.77
|
8.62 pg/mL
Standard Deviation 3.08
|
|
Interleukin-6 (IL-6) Frequency
Month 8
|
8.51 pg/mL
Standard Deviation 4.73
|
8.69 pg/mL
Standard Deviation 4.14
|
8.19 pg/mL
Standard Deviation 3.23
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
The inflammatory marker IL-7 in CSF was examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Interleukin-7 (IL-7) Frequency
Baseline
|
1.88 pg/mL
Standard Deviation 1.77
|
1.70 pg/mL
Standard Deviation 1.57
|
1.77 pg/mL
Standard Deviation 1.17
|
|
Interleukin-7 (IL-7) Frequency
Month 8
|
2.06 pg/mL
Standard Deviation 1.84
|
1.16 pg/mL
Standard Deviation 0.66
|
1.03 pg/mL
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
The inflammatory marker IL-8 in CSF was examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Interleukin-8 (IL-8) Frequency
Baseline
|
123.77 pg/mL
Standard Deviation 64.31
|
156.99 pg/mL
Standard Deviation 49.10
|
165.40 pg/mL
Standard Deviation 100.25
|
|
Interleukin-8 (IL-8) Frequency
Month 8
|
103.31 pg/mL
Standard Deviation 42.88
|
102.11 pg/mL
Standard Deviation 25.84
|
122.99 pg/mL
Standard Deviation 51.36
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
The inflammatory marker IL-9 in CSF was examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Interleukin-9 (IL-9) Frequency
Baseline
|
96.55 pg/mL
Standard Deviation 64.31
|
153.65 pg/mL
Standard Deviation 71.26
|
119.18 pg/mL
Standard Deviation 79.53
|
|
Interleukin-9 (IL-9) Frequency
Month 8
|
81.24 pg/mL
Standard Deviation 34.06
|
98.32 pg/mL
Standard Deviation 28.48
|
88.22 pg/mL
Standard Deviation 39.96
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
The inflammatory marker IL-10 in CSF was examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Interleukin-10 (IL-10) Frequency
Baseline
|
9.70 pg/mL
Standard Deviation 3.31
|
11.93 pg/mL
Standard Deviation 3.32
|
10.92 pg/mL
Standard Deviation 3.09
|
|
Interleukin-10 (IL-10) Frequency
Month 8
|
8.83 pg/mL
Standard Deviation 2.31
|
10.15 pg/mL
Standard Deviation 2.85
|
10.60 pg/mL
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Monocyte chemoattractant protein 1 inflammatory markers in CSF were examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Monocyte Chemoattractant Protein 1 (MCP-1) Frequency
Baseline
|
3369.30 pg/mL
Standard Deviation 1180.22
|
3347.26 pg/mL
Standard Deviation 786.79
|
3606.96 pg/mL
Standard Deviation 1077.71
|
|
Monocyte Chemoattractant Protein 1 (MCP-1) Frequency
Month 8
|
2069.32 pg/mL
Standard Deviation 735.75
|
2343.98 pg/mL
Standard Deviation 487.36
|
2548.37 pg/mL
Standard Deviation 872.88
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Macrophage derived protein 1 inflammatory markers in CSF were examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Macrophage Derived Protein 1 (MDC-1) Frequency
Baseline
|
23.68 pg/mL
Standard Deviation 30.61
|
13.12 pg/mL
Standard Deviation 22.27
|
30.88 pg/mL
Standard Deviation 67.71
|
|
Macrophage Derived Protein 1 (MDC-1) Frequency
Month 8
|
6.70 pg/mL
Standard Deviation 4.84
|
9.47 pg/mL
Standard Deviation 5.46
|
10.40 pg/mL
Standard Deviation 4.41
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Transforming growth factor alpha inflammatory markers in CSF were examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Transforming Growth Factor Alpha (TGF-α) Frequency
Baseline
|
9.42 pg/mL
Standard Deviation 2.29
|
9.58 pg/mL
Standard Deviation 1.65
|
9.05 pg/mL
Standard Deviation 1.71
|
|
Transforming Growth Factor Alpha (TGF-α) Frequency
Month 8
|
7.56 pg/mL
Standard Deviation 2.08
|
7.07 pg/mL
Standard Deviation 1.61
|
7.25 pg/mL
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Tumor necrosis factor alpha inflammatory markers in CSF were examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Tumor Necrosis Factor Alpha (TNF-α) Frequency
Baseline
|
4.54 pg/mL
Standard Deviation 4.12
|
6.72 pg/mL
Standard Deviation 4.68
|
5.17 pg/mL
Standard Deviation 3.28
|
|
Tumor Necrosis Factor Alpha (TNF-α) Frequency
Month 8
|
2.96 pg/mL
Standard Deviation 0.94
|
3.12 pg/mL
Standard Deviation 0.98
|
4.71 pg/mL
Standard Deviation 8.63
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Intercellular adhesion molecule 1 inflammatory markers in CSF were examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Intercellular Adhesion Molecule 1 (ICAM-1) Frequency
Baseline
|
207.81 ng/mL
Standard Deviation 107.74
|
310.55 ng/mL
Standard Deviation 258.73
|
205.18 ng/mL
Standard Deviation 179.56
|
|
Intercellular Adhesion Molecule 1 (ICAM-1) Frequency
Month 8
|
472.01 ng/mL
Standard Deviation 385.47
|
461.41 ng/mL
Standard Deviation 290.66
|
591.69 ng/mL
Standard Deviation 494.44
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Vascular cell adhesion molecule 1 inflammatory markers in CSF were examined.
Outcome measures
| Measure |
Telmisartan 20mg
n=9 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=16 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency
Baseline
|
12585.04 ng/mL
Standard Deviation 10891.20
|
16838.79 ng/mL
Standard Deviation 9151.95
|
13807.56 ng/mL
Standard Deviation 8991.60
|
|
Vascular Cell Adhesion Molecule 1 (VCAM-1) Frequency
Month 8
|
12964.43 ng/mL
Standard Deviation 2893.44
|
172781.50 ng/mL
Standard Deviation 4513.46
|
19212.32 ng/mL
Standard Deviation 8557.18
|
SECONDARY outcome
Timeframe: Baseline, Month 8Population: MMP was not analyzed because since developing the protocol for this study much has been learned about inflammatory cytokines and chemokines as AD preclinical biomarkers. The biological assay menu options for group analyses changed to include only those that have been shown to be related to disease state and likelihood of progression. The marker MMP was removed from the preplanned menu of inflammatory markers by the manufacturer and having MMP analyzed independently was cost prohibitive.
Matrix metalloproteinase inflammatory markers will be examined in CSF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 8Population: TIMP was not analyzed because since developing the protocol for this study much has been learned about inflammatory cytokines and chemokines as AD preclinical biomarkers. The biological assay menu options for group analyses changed to include only those that have been shown to be related to disease state and likelihood of progression. The marker TIMP was removed from the preplanned menu of inflammatory markers by the manufacturer and having TIMP analyzed independently was cost prohibitive.
Tissue inhibitor of metalloproteinase inflammatory markers will be examined in CSF.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 8Population: This analysis includes participants who completed 8 months of study treatment, attended the Month 8 study visit, and had a sufficient sample of CSF collected. The amount of CSF collected fluctuated and some samples were not of adequate quantity to be used for every lab measurement. In some cases, participants had an unsuccessful or inadequate lumbar puncture at Baseline and then had a successful lumbar puncture at the Month 8 visit.
Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ) is a marker of breakdown in the blood brain barrier. Increased levels of sPDGFRβ indicate cognitive dysfunction.
Outcome measures
| Measure |
Telmisartan 20mg
n=8 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=12 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=13 Participants
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)
Baseline
|
600.30 pg/mL
Standard Deviation 299.60
|
432.02 pg/mL
Standard Deviation 210.85
|
403.74 pg/mL
Standard Deviation 156.44
|
|
CSF-Soluble Platelet-Derived Growth Factor Receptor Beta (sPDGFRβ)
Month 8
|
470.93 pg/mL
Standard Deviation 104.50
|
391.10 pg/mL
Standard Deviation 151.23
|
471.60 pg/mL
Standard Deviation 190.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 8High-resolution anatomical images will be acquired using a 3D-Fast Spoiled Gradient Recalled Echo (FSPGR) Sequence. White Matter Hyperintensities (WMH) will be identified by a 3D T2 Fluid Attenuated Inversion Recovery (FLAIR) Fast Spin Echo sequence. The images will be co-registered using a within-subject inter-modal alignment between structural and perfusion images. T1-weighted Spoiled Gradient Recalled (SPGR) images will be used to identify cerebrospinal fluid and white and gray matter. Increased volumes of white matter hyperintensities indicate impaired cognitive function.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 8Echoplanar T1 mapping scans will be used for image registration and a scout image of the head will be obtained in order to choose the appropriate location for spin labeling and flow imaging. Arterial Spin Labeling images will be acquired using a custom 3D stack of interleaved spirals fast spin echo sequences and will be averaged in order to improve the signal-to-noise ratio. Images will be interpolated and smoothed in a panel by using a 0.5-pixel, full-width, half-maximum Gaussian kernel. Regional perfusion will be quantified in each hemisphere and maps of cerebral vasoreactivity will be obtained by co-registration of perfusion and anatomical images.
Outcome measures
Outcome data not reported
Adverse Events
Telmisartan 20mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Telmisartan 40mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Telmisartan 20mg
n=19 participants at risk
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 20 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Telmisartan 40mg
n=18 participants at risk
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive 40 mg of telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
Placebo
n=24 participants at risk
African American participants with untreated or treated hypertension and at high risk for Alzheimer's disease who were randomly assigned to receive a placebo to match telmisartan to be taken orally once a day before bedtime, for a duration of 8 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.8%
3/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
8.3%
2/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Excessive swelling
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
8.3%
2/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Cardiac disorders
Hypotension
|
10.5%
2/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Cardiac disorders
Postural hypotension
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
11.1%
2/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Persistent cough
|
21.1%
4/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
5.6%
1/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Dizziness
|
15.8%
3/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
11.1%
2/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
8.3%
2/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Cardiac disorders
Angina pectoris
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
8.3%
2/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Cardiac disorders
Angioedema
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
10.5%
2/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Syncope
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Vertigo
|
15.8%
3/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
5.6%
1/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Renal and urinary disorders
Abnormal kidney function
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Gastrointestinal disorders
Diarrhea
|
42.1%
8/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
11.1%
2/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Musculoskeletal and connective tissue disorders
Unusual muscle aches
|
36.8%
7/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
27.8%
5/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
12.5%
3/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Fatigue
|
10.5%
2/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
5.6%
1/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Sore throat
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Headache
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
5.6%
1/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
8.3%
2/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Dry mouth
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
11.1%
2/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Night sweats
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Out of range labs
|
5.3%
1/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Infections and infestations
Cold symptoms
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
5.6%
1/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Increased body temperature
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Gastrointestinal disorders
Acid reflux
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Trouble falling asleep
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Difficulty swallowing
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Cardiac disorders
Heart palpitations
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Low energy
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
|
General disorders
Weight loss
|
0.00%
0/19 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
0.00%
0/18 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
4.2%
1/24 • Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment at Month 8.
Participants were asked if they had experienced specific, anticipated adverse events. There was also a field for reporting other adverse events that were not specified.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place