Study to Evaluate the Preliminary Safety, Efficacy, PK and PD of Bryostatin 1 in Patients With Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT02221947|
Recruitment Status : Terminated (Part 2 of study replaced by NTRP-101-202, assessing 3 doses of bryostatin.)
First Posted : August 21, 2014
Results First Posted : April 21, 2016
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Bryostatin 1 Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Preliminary Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Bryostatin 1 in Patients With Alzheimer's Disease|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: Bryostatin 1
single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour
Drug: Bryostatin 1
25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour.
Placebo Comparator: placebo
single dose of placebo, intravenous infusion over 1 hour
Placebo, single dose via intravenous infusion over 1 hour.
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Within 2 weeks of study drug dosing ]Evaluate the safety and tolerability of bryostatin 1 (hereinafter referred to as bryostatin) in patients with Alzheimer's Disease (AD) following a single intravenous (IV) dose.
- Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD [ Time Frame: 48 hours post start of study drug infusion ]
Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall; change from baseline. HVLT consists of a 12-item word list drawn from 3 semantic categories, presented in 3 learning trials. Score range = 0-12. The lower the number, the more impaired.
Repeatable Battery of Assessments for Neuropsychological Status (RBANS) figure recall; change from baseline. Total Score Range: 0-20. Each portion of the drawing is scored 1 point for correctness and completeness and 1 point for being placed properly in relation to the rest of the drawing. Drawing and placement scores are summed for the item total. To obtain subtest total score, the drawing and placement scores are summed for each item. The lower the number, the more impaired.
- Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD [ Time Frame: Specified timepoints within 2 weeks post study drug infusion ]
HVLT-R (Hopkins Verbal Learning Test-Revised™) delayed recall (change from baseline). A 12-item word list: 3 learning trials. Score range = 0-12. The lower the number, the more impaired.
Repeatable Battery of Assessments for Neuropsychological Status (RBANS) figure recall; change from baseline. Score Range: 0-20. The lower the number, the more impaired. Digit Symbol Coding (observed), Score range: 0-125. The lower the number, the more impaired.
Clinical Dementia Rating- Sum of Boxes (CDR-SB, observed). Sum of 6 investigated domains (Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, Personal Care). Each subtest range is 0-3; Sum of all 6 subtest scores gives total CDR-SB score (range= 0-18).The higher the number, the more impaired.
Mini Mental State Exam, version 2 (MMSE-2), change from baseline. The MMSE-2 measures aspects of cognitionon a scale of 0-30. Lower scores indicate greater cognitive impairment.
- Pharmacokinetic Parameters of Bryostatin. [ Time Frame: Bryostatin plasma concentration pre-dose and at 15 min, 30 min, 1 hr, 1.5 hr, 2hr, 3hr and 6rs post dose. ]Preliminary evaluation of pharmacokinetics and pharmacodynamics (Cmax, Tmax, AUClast).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221947
|United States, California|
|California Clinical Trials Medical Center|
|Glendale, California, United States, 91206|
|Principal Investigator:||Hakop Gevorkyan, MD, MBA||California Clinical Trials Medical Group|