NCT02431468

A Randomized, Double-Blind,Placebo-Controlled, Phase 2 Study Assessing the Safety, Tolerability and Efficacy of Bryostatin in the Treatment of Moderately Severe to Severe Alzheimer's Disease

Completed Phase 2 Results posted Last updated 6 June 2018

What this trial tests

Phase 2 trial testing Bryostatin 1 in Alzheimer's Disease in 147 participants. Completed in 1 February 2017.

Timeline

1 November 2015

Primary endpoint
1 February 2017

1 February 2017

Quick facts

Lead sponsor	Neurotrope Bioscience, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	147
Start date	1 November 2015
Primary completion	1 February 2017
Estimated completion	1 February 2017
Sites	29 locations across United States

Drugs / interventions tested

• Bryostatin 1 — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Neurotrope Bioscience, Inc. — full company profile →

Who can join

Adults 55 to 85, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events
  Time frame: Baseline through 30 days post end of treatment (up to Day 107)
  Evaluations of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia
• Efficacy: Change From Baseline in Severe Impairment Battery (SIB) in the Full Analysis Set (FAS)
  Time frame: Primary analysis at Week 13 (day 91) after 12 weeks of treatment (up to day 107)
  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, o

Sponsor's own description

This is a randomized double-blind placebo-controlled study comparing different doses of bryostatin for the treatment of moderately severe to severe Alzheimer's disease. The study is 15 weeks in duration, including a safety and efficacy evaluation 30 days after the last dose of study drug.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alzheimer's disease drug development pipeline: 2018.
   Cummings J, Lee G, Ritter A, Zhong K. · · 2018 · cited 402× · PMID 29955663 · DOI 10.1016/j.trci.2018.03.009
2. Alzheimer's disease drug development pipeline: 2017.
   Cummings J, Lee G, Mortsdorf T, Ritter A, et al · · 2017 · cited 258× · PMID 29067343 · DOI 10.1016/j.trci.2017.05.002
3. Alzheimer's drug-development pipeline: 2016.
   Cummings J, Morstorf T, Lee G. · · 2016 · cited 78× · PMID 29067309 · DOI 10.1016/j.trci.2016.07.001
4. Pharmacotherapy of Alzheimer's Disease: Seeking Clarity in a Time of Uncertainty.
   Husna Ibrahim N, Yahaya MF, Mohamed W, Teoh SL, et al · · 2020 · cited 47× · PMID 32265696 · DOI 10.3389/fphar.2020.00261
5. New Drugs from Marine Organisms in Alzheimer's Disease.
   Russo P, Kisialiou A, Lamonaca P, Moroni R, et al · · 2015 · cited 41× · PMID 26712769 · DOI 10.3390/md14010005
6. Predominately Uncultured Microbes as Sources of Bioactive Agents.
   Newman DJ. · · 2016 · cited 22× · PMID 27917159 · DOI 10.3389/fmicb.2016.01832
7. Contrasting effect of the latency-reversing agents bryostatin-1 and JQ1 on astrocyte-mediated neuroinflammation and brain neutrophil invasion.
   Proust A, Barat C, Leboeuf M, Drouin J, et al · · 2017 · cited 17× · PMID 29228979 · DOI 10.1186/s12974-017-1019-y
8. Drug Development in Alzheimer's Disease: The Contribution of PET and SPECT.
   Declercq LD, Vandenberghe R, Van Laere K, Verbruggen A, et al · · 2016 · cited 16× · PMID 27065872 · DOI 10.3389/fphar.2016.00088