Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia (NCT NCT02886494)
NCT ID: NCT02886494
Last Updated: 2022-10-13
Results Overview
The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
COMPLETED
PHASE2
80 participants
Week 12
2022-10-13
Participant Flow
Recruitment was conducted in the United States. The study was open for recruitment in December 2016 and the first participant was successfully enrolled in January 2017.
The planned sample size was determined to be 45 versus 15 patients (3:1 ratio) for BAC treatment versus vehicle groups, 60 evaluable patients in total. To ensure the completion of 60 evaluable patients, around 75 patients were planned to be recruited. Actually, in this study, 80 eligible subjects were recruited and 59 evaluable subjects were achieved.
Participant milestones
| Measure |
BAC Treatment
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks.
Subjects were randomized 3:1 to receive double blind treatment of BAC or matched vehicle
|
Matched Vehicle
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
20
|
|
Overall Study
COMPLETED
|
43
|
16
|
|
Overall Study
NOT COMPLETED
|
17
|
4
|
Reasons for withdrawal
| Measure |
BAC Treatment
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks.
Subjects were randomized 3:1 to receive double blind treatment of BAC or matched vehicle
|
Matched Vehicle
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
3
|
|
Overall Study
Protocol Violation
|
4
|
1
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of BAC in Patient With Alzheimer's Disease or Vascular Dementia
Baseline characteristics by cohort
| Measure |
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks.
Subjects were randomized 3:1 to receive double blind treatment of BAC or matched vehicle
|
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 9.65 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 9.19 • n=7 Participants
|
73.2 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Africa Americans
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasians
|
54 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Dementia history
Alzheimer's Disease
|
42 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Dementia history
Mixed Dementia
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Dementia history
Vascular Dementia
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: All randomized patients who have received at least one dose of study medication.
The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=16 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=44 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in Alzheimer Disease Assessment Scale-cognitive (ADAS-cog) Score at Week 12 Visit Compared to Baseline
|
-2.25 score on a scale
Standard Deviation 4.973
|
-0.05 score on a scale
Standard Deviation 5.726
|
SECONDARY outcome
Timeframe: Week 4, 8Population: All randomized patients who have received at least one dose of study medication.
The Alzheimer's Disease Assessment Scale- Cognitive (ADAS-Cog) Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. It consists of 11 parts: 1. Word Recall Task; 2. Naming Task; 3: Commands; 4: Constructional Praxis; 5. Ideational Praxis; 6. Orientation; 7. Word Recognition Task; 8. Language; 9. Comprehension of Spoken Language; 10. Word Finding Difficulty; and 11. Remembering Test Instructions. Scores range from 0 to 70 with lower scores indicating lesser severity. ADAS-Cog was measured at Screening, Randomization/Baseline, Week 4, Week 8 and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in ADAS-cog Score at All Post Treatment Visits (Except Week 12 Visit) Compared to Baseline
Week 4 - Baseline
|
-2.33 score on a scale
Standard Deviation 4.393
|
-0.51 score on a scale
Standard Deviation 4.096
|
|
Change in ADAS-cog Score at All Post Treatment Visits (Except Week 12 Visit) Compared to Baseline
Week 8 - Baseline
|
-2.06 score on a scale
Standard Deviation 5.068
|
-0.79 score on a scale
Standard Deviation 4.177
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
This is a global measure of detectable change in cognition, function and behavior. The format for CIBIS/CIBIC-Plus consists of the assessment of an independent clinician based on observation of the patient at an interview, and information provided by the caregiver. The clinician's assessing severity at baseline and overall impression for assessing severity of the global change in disease severity, compared with baseline, is rated. The CIBIS/CIBIC plus examined general, cognitive, and behavioral function and activities of daily living on a 7-point categorical rating scale, ranging from a score of 0 indicating "Not assessed", to a score of 7 indicating "Among the most extremely ill patients" for CIBIS and ranging from 1 indicating "Very much improved", to a score of 7 indicating "Marked worsening", and with a score of 4 indicating "no change" for CIBIC-Plus. CIBIS was measured at Randomization visit and CIBIC-Plus was measured at Week 4, Week 8, and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 4 · 1. Very much improved
|
0 Participants
|
0 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 4 · 2. Much improved
|
1 Participants
|
1 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 4 · 3. Minimal improved
|
3 Participants
|
6 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 4 · 4. No change
|
10 Participants
|
41 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 4 · 5. Minimal worsening
|
4 Participants
|
3 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 4 · 6. Moderate worsening
|
0 Participants
|
0 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 8 · 1. Very much improved
|
0 Participants
|
0 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 8 · 2. Much improved
|
1 Participants
|
1 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 8 · 3. Minimal improved
|
1 Participants
|
2 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 8 · 4. No change
|
13 Participants
|
36 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 8 · 5. Minimal worsening
|
2 Participants
|
8 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 8 · 6. Moderate worsening
|
0 Participants
|
1 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 12 · 1. Very much improved
|
0 Participants
|
1 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 12 · 2. Much improved
|
2 Participants
|
1 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 12 · 3. Minimal improved
|
0 Participants
|
2 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 12 · 4. No change
|
11 Participants
|
33 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 12 · 5. Minimal worsening
|
3 Participants
|
5 Participants
|
|
Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-plus) Score at All Post Treatment Visits
Week 12 · 6. Moderate worsening
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
An inventory of informant based items to assess activities of daily living and instrumental activities of daily living, i.e. functional performance, of Alzheimer's disease (AD). It consists of 23-item inventory of ADL, rated based on extent of assistance the patient requires (independently, with supervision, with physical help): 0 (total independence in performing an activity) to 4 (total inability to act independently). Each question varies in the number of options to choose. Total score range: 0 to 78; higher scores indicate less functional impairment. ADL will be measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Score at All Post Treatment Visits Compared to Baseline
Week 4 - Baseline
|
1.17 score on a scale
Standard Deviation 4.618
|
-0.71 score on a scale
Standard Deviation 3.613
|
|
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Score at All Post Treatment Visits Compared to Baseline
Week 8 - Baseline
|
0.53 score on a scale
Standard Deviation 6.084
|
0.08 score on a scale
Standard Deviation 3.188
|
|
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Score at All Post Treatment Visits Compared to Baseline
Week 12 - Baseline
|
1.75 score on a scale
Standard Deviation 5.422
|
0.23 score on a scale
Standard Deviation 3.241
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The score ranges from 0 to 30, with higher scores indicating better cognitive function. MMSE was measured at Screening, Randomization/Baseline, Week 4, Week 8, and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in Mini-Mental State Examination (MMSE) Score at All Post Treatment Visits Compared to Baseline
Week 12 - Baseline
|
0.56 score on a scale
Standard Deviation 2.476
|
0.43 score on a scale
Standard Deviation 2.182
|
|
Change in Mini-Mental State Examination (MMSE) Score at All Post Treatment Visits Compared to Baseline
Week 4 - Baseline
|
0.17 score on a scale
Standard Deviation 2.431
|
0.61 score on a scale
Standard Deviation 2.089
|
|
Change in Mini-Mental State Examination (MMSE) Score at All Post Treatment Visits Compared to Baseline
Week 8 - Baseline
|
1.35 score on a scale
Standard Deviation 2.691
|
0.25 score on a scale
Standard Deviation 1.732
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI, section A\~J) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Frequency × Severity
Week 4 - Baseline
|
-2.28 score on a scale
Standard Deviation 6.952
|
-0.37 score on a scale
Standard Deviation 8.607
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Frequency × Severity
Week 8 - Baseline
|
-2.76 score on a scale
Standard Deviation 6.250
|
-0.75 score on a scale
Standard Deviation 4.024
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Frequency × Severity
Week 12 - Baseline
|
-3.13 score on a scale
Standard Deviation 6.672
|
-1.48 score on a scale
Standard Deviation 6.550
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 10 behavioral domains (10-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-10 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Caregiver Distress Score
Week 12 - Baseline
|
-2.25 score on a scale
Standard Deviation 4.740
|
-0.91 score on a scale
Standard Deviation 2.595
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Caregiver Distress Score
Week 4 - Baseline
|
-1.94 score on a scale
Standard Deviation 4.094
|
-0.02 score on a scale
Standard Deviation 2.839
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-10 Caregiver Distress Score
Week 8 - Baseline
|
-2.06 score on a scale
Standard Deviation 4.451
|
-0.52 score on a scale
Standard Deviation 1.902
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. Frequency is scored from 1 (occasionally) to 4 (very frequently) and severity is rated from 1 (mild) to 3 (severe). The score for each domain is frequency multiplied by severity. Therefore, the score ranges from 1 to 12 with higher scores indicate worse condition. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Frequency × Severity Score
Week 4 - Baseline
|
-3.89 score on a scale
Standard Deviation 9.074
|
-0.61 score on a scale
Standard Deviation 9.944
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Frequency × Severity Score
Week 8 - Baseline
|
-4.76 score on a scale
Standard Deviation 9.437
|
-1.29 score on a scale
Standard Deviation 6.348
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Frequency × Severity Score
Week 12 - Baseline
|
-5.50 score on a scale
Standard Deviation 10.047
|
-1.80 score on a scale
Standard Deviation 8.582
|
SECONDARY outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
The NPI is the behavior instrument most widely used in clinical trials of anti-dementia agents. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions. Both the frequency and the severity of each behavior are determined. Information for the NPI is obtained from a caregiver familiar with the patient's behavior. The NPI assesses 12 behavioral domains (12-item NPI) common in dementia. Each NPI domain is scored by the caregiver based on a standardized interview administered by the clinician. NPI-12 Caregiver Distress score is scored for associated caregiver distress from 0 (no distress) to 5 (very severe or extreme). Higher scores indicate greater distress. NPI was measured at Randomization/Baseline, Week 4, Week 8, and Week 12.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Caregiver Distress Score
Week 4 - Baseline
|
-2.56 score on a scale
Standard Deviation 5.193
|
-0.02 score on a scale
Standard Deviation 3.010
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Caregiver Distress Score
Week 8 - Baseline
|
-2.76 score on a scale
Standard Deviation 5.815
|
-0.67 score on a scale
Standard Deviation 2.291
|
|
Change in Neuropsychiatric Inventory (NPI) Score at All Post Treatment Visits Compared to Baseline: NPI-12 Caregiver Distress Score
Week 12 - Baseline
|
-3.13 score on a scale
Standard Deviation 6.174
|
-0.93 score on a scale
Standard Deviation 2.840
|
SECONDARY outcome
Timeframe: AEs were reported through the study completion (up to 12 weeks)Population: All randomized patients who have received at least one dose study medication.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. Laboratory abnormalities should not be recorded as AEs unless determined to be clinically significant by the Investigator. The number of participants with adverse events within the BAC and placebo groups was determined.
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Number of Participants With Adverse Events
|
7 Participants
|
20 Participants
|
POST_HOC outcome
Timeframe: Week 4, 8, 12Population: All randomized patients who have received at least one dose of study medication.
This is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial abilities and language. The maximum score is 30, with higher scores indicating better cognitive function. ). "Responder" analysis consist of two steps. (1) The baseline MMSE score is deducted from the post-treatment visit MMSE score; (2) the minus baseline score in step 1 is being dichotomized into two binary variable of either "responder" or "non-responder". Patients who make progress or remain unchanged on the cognitive test compared to baseline are considered as "responders", whereas patients who have deterioration on the cognitive test compared to baseline are considered as "non-responders".
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
"Responder" Analysis of MMSE Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Week 4 - baseline
|
5 Participants
|
13 Participants
|
|
"Responder" Analysis of MMSE Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Week 8 - baseline
|
6 Participants
|
12 Participants
|
|
"Responder" Analysis of MMSE Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Week 12 - baseline
|
5 Participants
|
12 Participants
|
POST_HOC outcome
Timeframe: Week 4, 8, and 12Population: All randomized patients who have received at least one dose of study medication.
The ADAS-Cog Subscale test is the standard assessment tool and one of the most popular cognitive testing instrument in clinical trials. It is designed to assess various cognitive abilities such as those associated with memory, language and praxis. Scores range from 0 to 70 with lower scores indicating lesser severity. "Responder" analysis consist of two steps. (1) The baseline ADAS-cog score score is deducted from the post-treatment visit ADAS-cog score; (2) the minus baseline score in step 1 is being dichotomized into two binary variable of either "responder" or "non-responder". Patients who make progress or remain unchanged on the cognitive test are considered as "responders", whereas patients who have deterioration on the cognitive test are considered as "non-responders".
Outcome measures
| Measure |
Matched Vehicle
n=20 Participants
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
BAC Treatment
n=60 Participants
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
"Responder" Analysis of ADAS-cog Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Week 4 - Baseline
|
7 Participants
|
13 Participants
|
|
"Responder" Analysis of ADAS-cog Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Week 8 - Baseline
|
6 Participants
|
10 Participants
|
|
"Responder" Analysis of ADAS-cog Score at All Post Treatment Visits Compared to Baseline, on All Subjects Not Receiving Any Dementia Medication (Naïve)
Week 12 - Baseline
|
4 Participants
|
11 Participants
|
Adverse Events
BAC Treatment
Matched Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BAC Treatment
n=60 participants at risk
BAC, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
Matched Vehicle
n=20 participants at risk
BAC matched vehicle, topically on external nasal skin, scalp, and neck, 30 g/day, 2 times daily for 12 weeks
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Nervous system disorders
Headache
|
5.0%
3/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
10.0%
2/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
10.0%
2/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.7%
1/60 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
5.0%
1/20 • AE data was collected from Screening visit to Final visit (up to 12 weeks)
All enrolled subjects were used for the analysis of AE and SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place