Trial Outcomes & Findings for A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD (NCT NCT05686044)
NCT ID: NCT05686044
Last Updated: 2025-04-29
Results Overview
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) measures cognitive functions and non-cognitive functions such as mood and behavior. It was designed to measure the cognitive and behavioral domains known to be affected in Alzheimer disease, including memory, language, orientation, construction, and planning of simple designs, and completed simple goal-oriented behaviors. Specifically, the ADAS-Cog comprises ratings from 11 components: word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instructions, spoken language, word finding, and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
351 participants
Primary outcome timeframe
Baseline to the end of treatment period (12 weeks)
Results posted on
2025-04-29
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
89
|
88
|
87
|
87
|
|
Overall Study
COMPLETED
|
82
|
84
|
80
|
79
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
7
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD
Baseline characteristics by cohort
| Measure |
Placebo
n=89 Participants
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=88 Participants
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
n=87 Participants
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
n=87 Participants
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 6.97 • n=5 Participants
|
73.6 years
STANDARD_DEVIATION 7.28 • n=7 Participants
|
74.7 years
STANDARD_DEVIATION 6.06 • n=5 Participants
|
73.1 years
STANDARD_DEVIATION 6.15 • n=4 Participants
|
73.6 years
STANDARD_DEVIATION 6.64 • n=21 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
210 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
207 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
312 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Mini-Mental State Examination (MMSE)
|
20.2 units on a scale
STANDARD_DEVIATION 3.04 • n=5 Participants
|
19.6 units on a scale
STANDARD_DEVIATION 3.23 • n=7 Participants
|
20.0 units on a scale
STANDARD_DEVIATION 3.06 • n=5 Participants
|
20.0 units on a scale
STANDARD_DEVIATION 2.82 • n=4 Participants
|
20.0 units on a scale
STANDARD_DEVIATION 3.04 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of treatment period (12 weeks)Population: Participants with ADAS-Cog11 scores at Baseline and 12 weeks (intent-to-treat population)
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) measures cognitive functions and non-cognitive functions such as mood and behavior. It was designed to measure the cognitive and behavioral domains known to be affected in Alzheimer disease, including memory, language, orientation, construction, and planning of simple designs, and completed simple goal-oriented behaviors. Specifically, the ADAS-Cog comprises ratings from 11 components: word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instructions, spoken language, word finding, and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment.
Outcome measures
| Measure |
Placebo
n=79 Participants
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=81 Participants
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
n=78 Participants
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
n=79 Participants
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in ADAS-Cog11
|
-2.32 units on a scale
Standard Error 0.533
|
-1.34 units on a scale
Standard Error 0.526
|
-3.01 units on a scale
Standard Error 0.534
|
-2.24 units on a scale
Standard Error 0.531
|
PRIMARY outcome
Timeframe: Baseline to the end of treatment period (12 weeks)Population: Participants with ADCS-CGIC scores at Baseline and 12 weeks (intent-to-treat population)
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. The ADCS-CGIC measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). Lower scores indicate better improvement.
Outcome measures
| Measure |
Placebo
n=82 Participants
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=84 Participants
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
n=80 Participants
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
n=79 Participants
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
ADCS-CGIC at Week 12
|
3.58 score on a scale
Standard Error 0.129
|
3.96 score on a scale
Standard Error 0.128
|
3.61 score on a scale
Standard Error 0.131
|
3.83 score on a scale
Standard Error 0.132
|
SECONDARY outcome
Timeframe: Baseline to end of treatment period (12 weeks)Population: Participants with ADCS-ADL scores at Baseline and 12 weeks (intent-to-treat population)
Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-ADL) is a 23-item inventory scale developed as a rater-administered questionnaire answered by the participant's study partner. The ADCS-ADL measures 6 basic activities of daily living (BADL) items and 17 instrumental activities of daily living (IADL) items that provide a total score from 0-78, with a lower score indicating greater severity. Basic activities include basic self-care tasks such as feeding, mobility, toileting, bathing, grooming and dressing. Instrumental activities are more complex and vary based on cultural norms, gender roles. As such, instrumental activities tend to include a broad range of activities. Caregivers are asked to rate the degree to which their family member or loved one can perform a variety of tasks. The assessed activities provide a total score from 0-78. Participants with a lower score indicates greater severity.
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=80 Participants
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
n=74 Participants
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
n=76 Participants
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in ADCS-ADL
|
2.03 units on a scale
Standard Error 0.811
|
-0.14 units on a scale
Standard Error 0.806
|
1.71 units on a scale
Standard Error 0.831
|
0.15 units on a scale
Standard Error 0.822
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to the end of treatment period (12 weeks)Population: Participants with analyzable plasma biomarker samples at Baseline and 12 weeks (intent-to-treat population). Plasma biomarkers were an exploratory endpoint; this analysis only included participants from the 30mg buntanetap/posiphen and placebo groups.
Plasma biomarkers measured: Glial fibrillary acidic protein (GFAP), Neurofilament light (NFL), TAR DNA-binding protein 43 (TDP43)
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=70 Participants
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Plasma Biomarkers
NFL
|
0.4 pg/ml
Standard Deviation 6.88
|
-2.5 pg/ml
Standard Deviation 14.05
|
—
|
—
|
|
Change From Baseline to Week 12 in Plasma Biomarkers
TDP43
|
-467.5 pg/ml
Standard Deviation 1474
|
-985.1 pg/ml
Standard Deviation 4950
|
—
|
—
|
|
Change From Baseline to Week 12 in Plasma Biomarkers
GFAP
|
5.5 pg/ml
Standard Deviation 74.32
|
2.1 pg/ml
Standard Deviation 69.44
|
—
|
—
|
POST_HOC outcome
Timeframe: Baseline to the end of treatment period (12 weeks)Population: AD biomarker positive participants (pTau217/t-Tau Ratio ≥4.2%) with Baseline MMSE Scores 21-24 and with ADAS-Cog11 scores at Baseline and 12 weeks
Change in the ADAS-Cog11 score from Baseline to the End of Trial. Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) measures cognitive functions and non-cognitive functions such as mood and behavior. It was designed to measure the cognitive and behavioral domains known to be affected in Alzheimer disease, including memory, language, orientation, construction, and planning of simple designs, and completed simple goal-oriented behaviors. Specifically, the ADAS-Cog comprises ratings from 11 components: word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instructions, spoken language, word finding, and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment.
Outcome measures
| Measure |
Placebo
n=18 Participants
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=20 Participants
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
n=22 Participants
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
n=22 Participants
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in ADAS-Cog11 for Biomarker Positive Participants With Baseline MMSE Scores 21-24
|
-0.26 units on a scale
Standard Error 0.911
|
-2.19 units on a scale
Standard Error 0.865
|
-2.79 units on a scale
Standard Error 0.815
|
-3.32 units on a scale
Standard Error 0.820
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
7.5mg Buntanetap/Posiphen
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
15mg Buntanetap/Posiphen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
30mg Buntanetap/Posiphen
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=88 participants at risk
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=86 participants at risk
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
n=85 participants at risk
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
n=87 participants at risk
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
1.1%
1/88 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.1%
1/87 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/88 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/87 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/88 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.1%
1/87 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/88 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.1%
1/87 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/88 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/87 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Gastrointestinal disorders
Oesophagitis
|
1.1%
1/88 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/87 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/88 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.1%
1/87 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/88 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.1%
1/87 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/88 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/86 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
0.00%
0/85 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.1%
1/87 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
Other adverse events
| Measure |
Placebo
n=88 participants at risk
Placebo oral capsule with daily administration for a period of 12 weeks
|
7.5mg Buntanetap/Posiphen
n=86 participants at risk
Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks
|
15mg Buntanetap/Posiphen
n=85 participants at risk
Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks
|
30mg Buntanetap/Posiphen
n=87 participants at risk
Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks
|
|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.1%
1/88 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
5.8%
5/86 • Number of events 6 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.2%
1/85 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
1.1%
1/87 • Number of events 1 • From consent to end of trial (up to 5 months)
A total of 5 participants were mistakenly randomized in the interactive response technology (IRT) system but did not meet inclusion/exclusion criteria at the time of initial treatment. Therefore, these participants did not receive study drug or placebo and were withdrawn from the study. This is the difference between enrollment/participant flow and the number of participants assessed for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Annovis Bio's agreements with its investigators may vary. However, Annovis Bio does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data for a clinical trial or for 12 months.
- Publication restrictions are in place
Restriction type: OTHER