Trial Outcomes & Findings for A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine (NCT NCT03560245)
NCT ID: NCT03560245
Last Updated: 2020-10-01
Results Overview
Incidence of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
Baseline through 30 days post end of treatment (up to Day 107)
Results posted on
2020-10-01
Participant Flow
111 subjects were randomized, but 3 subjects withdrew prior to receiving treatment. 108 subjects received treatment.
Participant milestones
| Measure |
Bryostatin 20µg
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
55
|
|
Overall Study
COMPLETED
|
48
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Bryostatin 20µg
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
The Safety Analysis Set (SAS) was defined as all randomized subjects who received any study medication (either partial or completed infusions of bryostatin or placebo).
Baseline characteristics by cohort
| Measure |
Bryostatin 20µg
n=53 Participants
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=55 Participants
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants • The Safety Analysis Set (SAS) was defined as all randomized subjects who received any study medication (either partial or completed infusions of bryostatin or placebo).
|
32 Participants
n=7 Participants • The Safety Analysis Set (SAS) was defined as all randomized subjects who received any study medication (either partial or completed infusions of bryostatin or placebo).
|
61 Participants
n=5 Participants • The Safety Analysis Set (SAS) was defined as all randomized subjects who received any study medication (either partial or completed infusions of bryostatin or placebo).
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants • The Safety Analysis Set (SAS) was defined as all randomized subjects who received any study medication (either partial or completed infusions of bryostatin or placebo).
|
23 Participants
n=7 Participants • The Safety Analysis Set (SAS) was defined as all randomized subjects who received any study medication (either partial or completed infusions of bryostatin or placebo).
|
47 Participants
n=5 Participants • The Safety Analysis Set (SAS) was defined as all randomized subjects who received any study medication (either partial or completed infusions of bryostatin or placebo).
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Safety Analysis Set
|
53 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 30 days post end of treatment (up to Day 107)Population: All participant who received at least one dose of study drug.
Incidence of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
Outcome measures
| Measure |
Bryostatin 20µg
n=53 Participants
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=55 Participants
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
Safety: Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
21 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: The change in the SIB Total Score from baseline to Week 13 (Day 91)Population: The Full Analysis Set (FAS) used for efficacy analyses was defined as all randomized subjects who received at least one dose of study medication and who have at least one post-baseline efficacy assessment.
The Severe Impairment Battery (SIB) assesses cognition in subjects with moderate and severe Alzheimer's disease(AD). Test questions measure attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a total point score range of 0-100. Lower scores indicate greater cognitive impairment.
Outcome measures
| Measure |
Bryostatin 20µg
n=52 Participants
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=54 Participants
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
Efficacy: The Primary Efficacy Endpoint is Defined as the Change From Baseline to Week 13 in the Severe Impairment Battery (SIB) Total Score in the Full Analysis Set
|
1.3 score on a scale
Standard Deviation 8.42
|
2.1 score on a scale
Standard Deviation 9.22
|
SECONDARY outcome
Timeframe: Weeks 5, 9 and 15 (up to Day 107)Population: At each timepoint, the number of participants whose data was obtained could vary from the number of subjects enrolled. There were occasions when subjects missed a visit or dropped out of the study, resulting in fewer data captured at that timepoint.
The Severe Impairment Battery (SIB) assesses cognition in subjects with Alzheimer's disease. SIB scores at Weeks 5, 9 and the Week 15 follow-up visit will be assessed. Test questions measure attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a total point score range of 0-100. Lower scores indicate greater cognitive impairment.
Outcome measures
| Measure |
Bryostatin 20µg
n=52 Participants
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=54 Participants
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
The Changes From Baseline at Weeks 5, 9 and 15 in the Severe Impairment Battery (SIB) Total Score in the Full Analysis Set.
Week 5
|
-0.1 score on a scale
Standard Deviation 7.94
|
0.7 score on a scale
Standard Deviation 11.0
|
|
The Changes From Baseline at Weeks 5, 9 and 15 in the Severe Impairment Battery (SIB) Total Score in the Full Analysis Set.
Week 9
|
2.7 score on a scale
Standard Deviation 7.18
|
1.4 score on a scale
Standard Deviation 8.23
|
|
The Changes From Baseline at Weeks 5, 9 and 15 in the Severe Impairment Battery (SIB) Total Score in the Full Analysis Set.
Week 15 or early termination
|
1.6 score on a scale
Standard Deviation 9.07
|
2.1 score on a scale
Standard Deviation 9.66
|
SECONDARY outcome
Timeframe: Weeks 5, 9, 13 and 15 (up to Day 107)Population: The MMSE-2 4-9 stratification group represents Severe Alzheimer's disease. The analysis population at each time point varies because of missed visits and dropouts.
The SIB is used to assess cognition in subjects with moderate and severe AD and is a useful outcome measure in advanced stages of disease. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.
Outcome measures
| Measure |
Bryostatin 20µg
n=18 Participants
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=18 Participants
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 4-9 Stratification Group
Week 5
|
-3.1 score on a scale
Standard Deviation 9.55
|
1.4 score on a scale
Standard Deviation 11.1
|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 4-9 Stratification Group
Week 9
|
1.1 score on a scale
Standard Deviation 8.98
|
1.1 score on a scale
Standard Deviation 13.3
|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 4-9 Stratification Group
Week 13
|
-3.6 score on a scale
Standard Deviation 7.42
|
1.9 score on a scale
Standard Deviation 15.3
|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 4-9 Stratification Group
Week 15/ Early Termination
|
-2.6 score on a scale
Standard Deviation 9.81
|
0.3 score on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Weeks 5, 9, 13 and 15 (up tp Day 107)Population: Mini Mental State Exam version 2 (MMSE-2) scores between 10 and 15 are representative of moderately severe Alzheimer's disease. The number of participants at each time point varies because of missed visits and dropouts.
Mini Mental State Exam version 2 (MMSE-2) scores between 10 and 15 are representative of moderately severe Alzheimer's disease. The SIB is used to assess cognition in subjects with moderate and severe AD and is a useful outcome measure in advanced stages of disease. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.
Outcome measures
| Measure |
Bryostatin 20µg
n=34 Participants
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=36 Participants
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 10-15 Stratification Group
Week 5
|
1.4 score on a scale
Standard Deviation 6.57
|
0.3 score on a scale
Standard Deviation 11.1
|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 10-15 Stratification Group
Week 9
|
3.5 score on a scale
Standard Deviation 6.13
|
1.5 score on a scale
Standard Deviation 4.61
|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 10-15 Stratification Group
Week 13
|
3.9 score on a scale
Standard Deviation 7.80
|
2.2 score on a scale
Standard Deviation 4.78
|
|
The Changes From Baseline at Weeks 5, 9, 13 and 15 in the Severe Impairment Battery (SIB) Total Score for Subjects in the Mini Mental State Exam Version 2 (MMSE-2) 10-15 Stratification Group
Week 15/Early Termination
|
3.7 score on a scale
Standard Deviation 8.03
|
2.8 score on a scale
Standard Deviation 4.74
|
SECONDARY outcome
Timeframe: Baseline through Week 13 (Day 91)Population: Full Analysis Set
Severe Impairment Battery (SIB) trend analyses will be assessed for individual patients. SIB scores were evaluated in subjects at various time points during the study. Individual-specific SIB slopes were estimated for all patients over each person's available SIB outcome measures.
Outcome measures
| Measure |
Bryostatin 20µg
n=52 Participants
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=54 Participants
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
Individual Patient's Slope Over Time in SIB Total Score Evaluated Via Weeks 0, 5, 9, and 13
Slope > 0
|
29 Participants
|
29 Participants
|
|
Individual Patient's Slope Over Time in SIB Total Score Evaluated Via Weeks 0, 5, 9, and 13
Slope < 0
|
23 Participants
|
23 Participants
|
|
Individual Patient's Slope Over Time in SIB Total Score Evaluated Via Weeks 0, 5, 9, and 13
Slope = 0
|
0 Participants
|
2 Participants
|
Adverse Events
Bryostatin 20µg
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Bryostatin 20µg
n=53 participants at risk
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=55 participants at risk
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
Injury, poisoning and procedural complications
Right Distal Femur Fracture
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Well-diferentiated invasive colorectal adenocarcino
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Nervous system disorders
Syncope
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.9%
1/53 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
General disorders
Death
|
0.00%
0/53 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
Other adverse events
| Measure |
Bryostatin 20µg
n=53 participants at risk
20µg Bryostatin administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Bryostatin: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
|
Placebo
n=55 participants at risk
Placebo administered IV over 45 minutes every other weekafter 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
5.7%
3/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
3.6%
2/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.5%
4/53 • Number of events 5 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 2 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.7%
3/53 • Number of events 3 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
0.00%
0/55 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
|
Psychiatric disorders
Agitation
|
11.3%
6/53 • Number of events 6 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
1.8%
1/55 • Number of events 1 • Treatment emergent adverse events (TEAEs) were defined as an event with onset on or after the first treatment administration. The time duration was 15 weeks, beginning on the date of the first dose, including a period of 30 days after the last study drug treatment.
|
Additional Information
Alan J. Tuchman, MD, Acting Chief Medical Officer
Neurotropebioscience, Inc
Phone: 973-242-0005
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60