Trial Outcomes & Findings for Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects (NCT NCT03817684)
NCT ID: NCT03817684
Last Updated: 2025-02-18
Results Overview
The RBANS is a brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. It consists of 12 subtests, which yield 5 Index scores and a Total Scale score. Lower scores indicate worse performance on the test (and thus greater impairment). Scores for the RBANS DMI range from 40 (greater impairment) to 160 (improved function), with higher scores indicating improved function.
COMPLETED
PHASE2
255 participants
Baseline, Week 13
2025-02-18
Participant Flow
Participant milestones
| Measure |
BPN14770 10mg Bid
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
Placebo: Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
84
|
85
|
86
|
|
Overall Study
Safety Population
|
80
|
85
|
86
|
|
Overall Study
COMPLETED
|
79
|
79
|
84
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects
Baseline characteristics by cohort
| Measure |
BPN14770 10mg Bid
n=80 Participants
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=85 Participants
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 Participants
Placebo: Placebo
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 7.54 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 7.21 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 7.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
103 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
225 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
|
80 participants
n=5 Participants
|
85 participants
n=7 Participants
|
86 participants
n=5 Participants
|
251 participants
n=4 Participants
|
|
Pre Treatment MMSE
|
24.2 scores on a scale
STANDARD_DEVIATION 2.04 • n=5 Participants
|
24.3 scores on a scale
STANDARD_DEVIATION 2.61 • n=7 Participants
|
24.6 scores on a scale
STANDARD_DEVIATION 2.44 • n=5 Participants
|
24.4 scores on a scale
STANDARD_DEVIATION 2.38 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 13Population: mITT Population
The RBANS is a brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. It consists of 12 subtests, which yield 5 Index scores and a Total Scale score. Lower scores indicate worse performance on the test (and thus greater impairment). Scores for the RBANS DMI range from 40 (greater impairment) to 160 (improved function), with higher scores indicating improved function.
Outcome measures
| Measure |
BPN14770 10mg Bid
n=80 Participants
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=84 Participants
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Change From Baseline in Repeatable Battery for the Assessment of Neurological Status- Delayed Memory Index (RBANS- DMI) at Week 13
|
10.1 scores on a scale
Standard Error 1.71
|
9.9 scores on a scale
Standard Error 1.67
|
9.7 scores on a scale
Standard Error 1.63
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: mITT
The RBANS is a brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. It consists of 12 subtests, which yield 5 Index scores and a Total Scale score. Lower scores indicate worse performance on the test (and thus greater impairment). The RBANS total score ranges from 40 to 160, with higher scores indicating improved function.
Outcome measures
| Measure |
BPN14770 10mg Bid
n=80 Participants
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=84 Participants
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Change From Baseline in Repeatable Battery for the Assessment of Neurological Status (RBANS) Total Score at Week 13
|
4.5 scores on a scale
Standard Error 0.98
|
5.2 scores on a scale
Standard Error 0.96
|
5.4 scores on a scale
Standard Error 0.94
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: mITT
The ADCS-ADL is an interviewer-administered informant-based scale where the informant (caregiver) responds to 23 activities of daily living questions about the participant. The questions range from basic to instrumental activities of daily living. The total score ranges from 0-78 and a higher score signifies greater functional ability.
Outcome measures
| Measure |
BPN14770 10mg Bid
n=80 Participants
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=84 Participants
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Total Score at Week 13
|
1.1 scores on a scale
Standard Error 0.55
|
1.5 scores on a scale
Standard Error 0.54
|
1.5 scores on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: mITT
The MMSE consists of 11 items covering orientation, memory (recent and immediate), concentration, language and praxis. Total score ranges from 0 (severe cognitive impairment) to 30 (intact cognitive function), with lower scores indicating greater cognitive impairment. In participants with a diagnosis of AD, lower scores indicating worse disease. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
Outcome measures
| Measure |
BPN14770 10mg Bid
n=80 Participants
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=84 Participants
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Change From Baseline in Mini-Mental State Exam (MMSE) Total Score at Week 13
|
0.7 scores on a scale
Standard Error 0.23
|
0.8 scores on a scale
Standard Error 0.23
|
0.8 scores on a scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, Week 13Population: mITT
The CDR was developed primarily to assess severity level in persons with dementia. Six domains were assessed and then synthesized to assign a Global CDR score. The domains were memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Impairment was defined only when caused by cognitive loss rather than by physical disability or other non-cognitive factors. CDR is an ordinal parameter (scale 0 \[least impairment\]-3 \[severe impairment\]). CDR-SB score was obtained by summing each of the domain box scores, with scores ranging from 0 (least impairment) to 18 (severe impairment).
Outcome measures
| Measure |
BPN14770 10mg Bid
n=80 Participants
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=84 Participants
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Change From Baseline in Clinical Dementia Rating Sum of Boxes Score (CDR-SB) at Week 13
|
0.25 scores on a scale
Standard Error 0.119
|
-0.05 scores on a scale
Standard Error 0.118
|
0.19 scores on a scale
Standard Error 0.114
|
SECONDARY outcome
Timeframe: Week 13Population: mITT
The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The Investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
Outcome measures
| Measure |
BPN14770 10mg Bid
n=80 Participants
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=84 Participants
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 Participants
Placebo: Placebo
|
|---|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I) Score
|
3.5 scores on a scale
Standard Error 0.10
|
3.3 scores on a scale
Standard Error 0.10
|
3.4 scores on a scale
Standard Error 0.10
|
Adverse Events
BPN14770 10mg Bid
BPN 14770 25mg Bid
Placebo
Serious adverse events
| Measure |
BPN14770 10mg Bid
n=80 participants at risk
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=85 participants at risk
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 participants at risk
Placebo: Placebo
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/80 • Number of events 1 • 13 weeks
|
0.00%
0/85 • 13 weeks
|
0.00%
0/86 • 13 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolsis
|
1.2%
1/80 • Number of events 1 • 13 weeks
|
0.00%
0/85 • 13 weeks
|
0.00%
0/86 • 13 weeks
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/80 • 13 weeks
|
0.00%
0/85 • 13 weeks
|
1.2%
1/86 • Number of events 1 • 13 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/80 • 13 weeks
|
0.00%
0/85 • 13 weeks
|
1.2%
1/86 • Number of events 1 • 13 weeks
|
|
Cardiac disorders
Presyncope
|
0.00%
0/80 • 13 weeks
|
1.2%
1/85 • Number of events 1 • 13 weeks
|
0.00%
0/86 • 13 weeks
|
|
Musculoskeletal and connective tissue disorders
Femoral Neck Fracture
|
0.00%
0/80 • 13 weeks
|
1.2%
1/85 • Number of events 1 • 13 weeks
|
0.00%
0/86 • 13 weeks
|
Other adverse events
| Measure |
BPN14770 10mg Bid
n=80 participants at risk
10 mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
BPN 14770 25mg Bid
n=85 participants at risk
25mg bid dose of the Drug BPN14770 BPN14770: Drug BPN14770
|
Placebo
n=86 participants at risk
Placebo: Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
5/80 • Number of events 5 • 13 weeks
|
7.1%
6/85 • Number of events 6 • 13 weeks
|
3.5%
3/86 • Number of events 3 • 13 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.0%
4/80 • Number of events 4 • 13 weeks
|
5.9%
5/85 • Number of events 5 • 13 weeks
|
0.00%
0/86 • 13 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place