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A Study Assessing Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT02431468
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Neurotrope Bioscience, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: Bryostatin 1
Other: Placebo
Enrollment 147
Recruitment Details Planned: 250 subjects to be screened for a total of 140 subjects randomized 1:1:1 to one of three treatment arms: 20μg, 40μg or placebo Actual: 264 subjects were screened. 147 individual subjects were randomized and of those, 141 were dosed with trial drug.
Pre-assignment Details  
Arm/Group Title Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Hide Arm/Group Description

Bryostatin 20 micrograms 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 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.

Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.

Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.

Period Title: Overall Study
Started [1] 46 47 48
Completed 38 29 39
Not Completed 8 18 9
Reason Not Completed
Adverse Event             2             4             5
Withdrawal by Subject             4             12             2
noncompliance, investigator termination,             2             2             2
[1]
Safety Analysis set
Arm/Group Title Bryostatin 1 20ug Bryostatin 1 40ug Placebo Total
Hide Arm/Group Description

Bryostatin 20 micrograms 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 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.

Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.

Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.

Total of all reporting groups
Overall Number of Baseline Participants 46 47 48 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 47 participants 48 participants 141 participants
71.2  (8.40) 70.2  (7.53) 73.5  (7.68) 71.7  (7.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 47 participants 48 participants 141 participants
Female
26
  56.5%
22
  46.8%
23
  47.9%
71
  50.4%
Male
20
  43.5%
25
  53.2%
25
  52.1%
70
  49.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 47 participants 48 participants 141 participants
White
42
  91.3%
46
  97.9%
45
  93.8%
133
  94.3%
African American
3
   6.5%
1
   2.1%
3
   6.3%
7
   5.0%
Asian
1
   2.2%
0
   0.0%
0
   0.0%
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 47 participants 48 participants 141 participants
46 47 48 141
Mini Mental State Exam-version 2 (MMSE-2) baseline scores 4-9   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 47 participants 48 participants 141 participants
18
  39.1%
20
  42.6%
19
  39.6%
57
  40.4%
[1]
Measure Description: ion, language, and praxis on a scale of 0-30. Lower scores indicate greater cognitive impairment. For this study, subjects were stratified at randomization based on Mini Mental State Exam version 2 (MMSE-2) scores 4-9 (severe cognitive impairment) and 10-15 (moderately severe impairment).
Mini Mental State Exam version 2 (MMSE-2) baseline score 10-15   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 47 participants 48 participants 141 participants
28
  60.9%
27
  57.4%
29
  60.4%
84
  59.6%
[1]
Measure Description: For this study, subjects were stratified at randomization by Mini Mental State Exam version 2 (MMSE-2) scores 4-9 (severe cognitive impairment) and 10-15 (moderately severe impairment)
1.Primary Outcome
Title Safety: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events
Hide Description Evaluations of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
Time Frame Baseline through 30 days post end of treatment (up to Day 107)
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Safety Analysis Set
Arm/Group Title Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Hide Arm/Group Description:

Bryostatin 20 micrograms 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 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.

Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.

Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.

Overall Number of Participants Analyzed 46 47 48
Measure Type: Number
Unit of Measure: participants
Number of Subjects w Treatment Emergent AE (TEAE) 30 39 28
# of Subjects w Treatment Related TEAE 17 24 8
# of Subjects w TEAE leading to treatment discont. 1 3 2
# of Subjects with Serious TEAE 1 6 3
# of Subjects with Treatment Related Serious TEAE 1 4 0
# of Subjects w Treatment Emergent Myalgia 1 4 0
# of Subjects w Serious Treatment Emergent Myalgia 0 0 0
# of Subjects with Fatal TEAE 0 1 0
2.Primary Outcome
Title Efficacy: Change From Baseline in Severe Impairment Battery (SIB) in the Full Analysis Set (FAS)
Hide Description The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the total SIB score after 12 weeks of treatment, assessed at Week 13 (day 91). Efficacy analyses were conducted according to randomized groups. The SIB is used to assess cognition in subjects with moderate and severe AD. 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.
Time Frame Primary analysis at Week 13 (day 91) after 12 weeks of treatment (up to day 107)
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Hide Analysis Population Description
The Full Analysis Set (FAS), consistent with a modified intention-to-treat principle (mITT), was defined as all randomized subjects who received at least one dose of randomized trial medication and who had at least one post-baseline assessment.
Arm/Group Title Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Hide Arm/Group Description:

Bryostatin 20 micrograms 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 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.

Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.

Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.

Overall Number of Participants Analyzed 44 45 46
Mean (Standard Deviation)
Unit of Measure: mean change from baseline in SIB score
Week 13 Full Analysis Set (FAS) Number Analyzed 38 participants 33 participants 42 participants
1.6  (7.10) 0.8  (6.58) -0.4  (9.02)
Week 13 Completer Analysis Set (CAS) Number Analyzed 38 participants 33 participants 42 participants
1.6  (7.10) 0.8  (6.58) -0.7  (9.02)
30-Day Followup Full Analysis Set Number Analyzed 27 participants 22 participants 29 participants
2.3  (8.17) 0.6  (7.51) -2.7  (11.44)
30-Day Followup Completer Analysis Set Number Analyzed 27 participants 20 participants 29 participants
2.3  (8.17) 0.9  (7.85) -2.7  (11.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bryostatin 1 20ug, Bryostatin 1 40ug, Placebo
Comments The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.1
Comments LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bryostatin 1 20ug, Bryostatin 1 40ug, Placebo
Comments Change from baseline in SIB in the Completer Analysis Set (CAS)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.1
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 6.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Secondary Efficacy Endpoints
Hide Description
  • Change from baseline in the Severe Impairment Battery (SIB) at Weeks 5 and 9. Assesses cognition. Score range 0-100. Lower scores indicate greater cognitive impairment.
  • Change from baseline in Alzheimer Disease Cooperative Study Activities of Daily Living Inventory-Severe Impairment Version (ADCS-ADL-SEV) at Weeks 5, 9,13. A 19-item test of the performance of activities of daily living. Total score range 0-54; lower scores indicate greater functional impairment.
  • Change from baseline in MMSE-2 at Weeks 5, 9 and 13. Tests selected aspects of cognition on a scale of 0-30. Lower scores indicate greater cognitive impairment.
  • Change from baseline in Neuropsychiatric Inventory (NPI) at Weeks 5, 9,13. Caregiver interview assesses 12 behavioral disturbances. Scores range from 0-144; higher scores indicate greater behavioral disturbances.
  • Clinical Global Impression of Improvement (CGI-I) at Weeks 5, 9, 13. A 7-point scale range from (1) very much improved to (7) very much worse.
Time Frame Week 5, Week 9, Week 13
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Hide Analysis Population Description
The number of participants analyzed over the course of the study diminished as a result of attrition.
Arm/Group Title Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Hide Arm/Group Description:

Bryostatin 20 micrograms 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 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.

Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.

Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.

Overall Number of Participants Analyzed 46 47 48
Mean (Standard Deviation)
Unit of Measure: mean change from baseline
SIB Week 5 Full Analysis Set Number Analyzed 44 participants 44 participants 46 participants
1.5  (7.36) -0.8  (6.55) -1.2  (10.31)
SIB Week 5 Completer Analysis Set Number Analyzed 38 participants 32 participants 42 participants
1.7  (6.02) 0.1  (5.93) -1.9  (10.33)
SIB Week 9 Full Analysis Set Number Analyzed 38 participants 38 participants 43 participants
1.3  (6.87) -0.2  (6.41) -0.0  (9.91)
SIB Week 9 Completer Analysis Set Number Analyzed 37 participants 33 participants 42 participants
1.2  (6.93) -0.1  (6.06) -0.1  (10.0)
Week 5 ADCS-ADL-SIV : FAS Number Analyzed 43 participants 43 participants 48 participants
-0.3  (4.16) -1.1  (6.31) -0.7  (5.07)
Week 9 ADCS-ADL-SIV : FAS Number Analyzed 37 participants 38 participants 43 participants
-1.4  (4.68) -1.5  (5.05) -1.3  (4.07)
Week 13 ADCS-ADL-SIV : FAS Number Analyzed 37 participants 33 participants 42 participants
-0.7  (4.59) -1.0  (4.86) -2.2  (5.28)
Week 5 MMSE-2: FAS Number Analyzed 44 participants 44 participants 46 participants
0.4  (2.43) -0.1  (2.79) -0.1  (2.40)
Week 9 MMSE-2: FAS Number Analyzed 38 participants 38 participants 43 participants
0.8  (2.98) 0.3  (3.01) 0.5  (3.11)
Week 13 MMSE-2: FAS Number Analyzed 38 participants 33 participants 42 participants
0.5  (3.09) 0.3  (2.54) -0.2  (3.49)
Week 5 Neuropsychiatric Inventory (NPI): FAS Number Analyzed 41 participants 41 participants 44 participants
-0.5  (11.72) 1.7  (12.03) -2.4  (10.31)
Week 9 Neuropsychiatric Inventory (NPI): FAS Number Analyzed 37 participants 34 participants 41 participants
0.5  (11.97) 2.0  (8.33) -2.5  (11.05)
Week 13 Neuropsychiatric Inventory (NPI): FAS Number Analyzed 37 participants 32 participants 39 participants
1.0  (12.62) 2.0  (11.94) 1.0  (10.45)
4.Post-Hoc Outcome
Title Severe Impairment Battery (SIB) Scores by Memantine Use at Baseline
Hide Description Change from baseline in SIB score was compared between subjects receiving concurrent treatment with memantine and subjects not being treated with memantine.
Time Frame Assessments at weeks 5, 9, 13, and 30 days after end of treatment (up to day 107).
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Hide Analysis Population Description
Participants in the 3 treatment groups were further sorted by use of memantine. The number of participants in each category at each timepoint is noted. Attrition occurred through the course of the study.
Arm/Group Title Bryostatin 1 20ug With Memantine Bryostatin 1 40ug With Memantine Placebo With Memantine Bryostatin 1 20ug Without Memantine Bryostatin 1 40ug Without Memantine Placebo Without Memantine
Hide Arm/Group Description:

Bryostatin 20 micrograms 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 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.

Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.

Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.

Bryostatin 20 micrograms 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 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.
Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.
Overall Number of Participants Analyzed 26 37 31 18 8 15
Mean (Standard Deviation)
Unit of Measure: mean change from baseline in SIB score
Week 5 SIB change from Baseline Number Analyzed 26 participants 37 participants 31 participants 18 participants 7 participants 15 participants
0.1  (8.11) -1.6  (6.50) -1.3  (10.50) 3.4  (5.75) 3.9  (4.98) -1.2  (10.26)
Week 9 SIB change from Baseline Number Analyzed 23 participants 31 participants 29 participants 15 participants 7 participants 15 participants
-0.1  (6.52) -0.6  (6.88) -0.4  (11.01) 3.5  (7.04) 2.0  (3.16) 0.8  (7.44)
Week 13 SIB change from Baseline Number Analyzed 22 participants 26 participants 28 participants 16 participants 7 participants 14 participants
-0.5  (6.51) -0.1  (6.61) -0.5  (10.03) 4.5  (7.01) 3.9  (5.84) -1.1  (6.89)
30-day Followup SIB change from Baseline Number Analyzed 15 participants 20 participants 18 participants 12 participants 2 participants 11 participants
-1.1  (8.39) 0.3  (7.71) -3.8  (13.10) 6.7  (5.58) 4.0  (5.66) -1.0  (8.31)
Time Frame Adverse event data was collected beginning at the time of informed consent until the 30-day post treatment visit. For subjects enrolled under protocol versions 1 (17 Apr 2015) and 2 (20 Jan 2016), this collection occurred from Day -21 through Day 198 for subjects completing the study. For subjects enrolled under protocol version 3 (15 Jul 2016) this collection occurred from Day -28 through Day 105.
Adverse Event Reporting Description In addition to the standard defined adverse events, an adverse event of special interest was defined in this study; myalgia.
 
Arm/Group Title Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Hide Arm/Group Description

Bryostatin 20 micrograms 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 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Bryostatin 40 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 48 micrograms administered weekly. A total of 7 doses administered over 12 weeks.

Bryostatin 1: The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.

Placebo administered IV over 45 minutes every other week after 2 initial doses administered weekly. A total of 7 doses administered over 12 weeks.

Placebo: The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.

All-Cause Mortality
Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)      1/47 (2.13%)      0/48 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/46 (4.35%)      6/47 (12.77%)      4/48 (8.33%)    
Cardiac disorders       
Atrial fibrillation   1/46 (2.17%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
General disorders       
Infusion Site Pain   1/46 (2.17%)  1 0/47 (0.00%)  0 0/48 (0.00%)  0
Infections and infestations       
Infusion site cellulitis   0/46 (0.00%)  0 2/47 (4.26%)  2 0/48 (0.00%)  0
Metabolism and nutrition disorders       
Diabetic ketoacidosis   0/46 (0.00%)  0 1/47 (2.13%)  1 0/48 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Ovarian cancer   0/46 (0.00%)  0 0/47 (0.00%)  0 1/48 (2.08%)  1
Bladder cancer   0/46 (0.00%)  0 0/47 (0.00%)  0 1/48 (2.08%)  1
Nervous system disorders       
Confusion postoperative   0/46 (0.00%)  0 0/47 (0.00%)  0 1/48 (2.08%)  1
Dementia Alzheimer's Type   0/46 (0.00%)  0 1/47 (2.13%)  1 0/48 (0.00%)  0
Seizure   0/46 (0.00%)  0 1/47 (2.13%)  1 0/48 (0.00%)  0
Syncope   0/46 (0.00%)  0 1/47 (2.13%)  1 0/48 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pneumonia   0/46 (0.00%)  0 0/47 (0.00%)  0 1/48 (2.08%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bryostatin 1 20ug Bryostatin 1 40ug Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/46 (45.65%)      46/47 (97.87%)      12/48 (25.00%)    
Gastrointestinal disorders       
Diarrhea   5/46 (10.87%)  6 5/47 (10.64%)  5 1/48 (2.08%)  1
General disorders       
Infusion site extravasation   3/46 (6.52%)  3 3/47 (6.38%)  4 0/48 (0.00%)  0
Fatigue   1/46 (2.17%)  1 5/47 (10.64%)  5 0/48 (0.00%)  0
Infusion site pain   3/46 (6.52%)  3 0/47 (0.00%)  0 1/48 (2.08%)  1
Infections and infestations       
Urinary tract infection   2/46 (4.35%)  2 3/47 (6.38%)  3 4/48 (8.33%)  4
Infusion site cellulitis   0/46 (0.00%)  0 4/47 (8.51%)  4 0/48 (0.00%)  0
Injury, poisoning and procedural complications       
Fall   1/46 (2.17%)  1 4/47 (8.51%)  5 1/48 (2.08%)  1
Contusion   1/46 (2.17%)  1 3/47 (6.38%)  3 0/48 (0.00%)  0
Investigations       
Weight decreased   0/46 (0.00%)  0 5/47 (10.64%)  5 0/48 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite   1/46 (2.17%)  1 6/47 (12.77%)  6 2/48 (4.17%)  2
Musculoskeletal and connective tissue disorders       
Myalgia   1/46 (2.17%)  1 4/47 (8.51%)  6 0/48 (0.00%)  0
Nervous system disorders       
Headache   3/46 (6.52%)  4 4/47 (8.51%)  4 3/48 (6.25%)  3
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Crockford, Vice President, Regulatory Affairs
Organization: Neurotrope BioScience, Inc.
Phone: (973)242-0005
Responsible Party: Neurotrope Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT02431468     History of Changes
Other Study ID Numbers: NTRP-101-202
First Submitted: April 22, 2015
First Posted: May 1, 2015
Results First Submitted: April 30, 2018
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018