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Protein Kinase C Modulator

Bryostatin 1 for Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by Neurotrope Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MMSE-2 score of 10-18 inclusive (applies to Screening Visit only)
Patients must have a baseline SIB total score of at least 60 and may not have a SIB score >93 at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up slopes will be estimated by using sib data at week 0, 5, 9, 13, 15, 20, 24, and 28
Awards & highlights

Study Summary

This trial will test if bryostatin is safe and effective for treating Alzheimer's disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The MMSE-2 score of 10-18 inclusive means that the person only has mild problems with their thinking skills.
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to be eligible for the study Patients must have a baseline score of at least 60 in the SIB total score measure and may not have a SIB score greater than 93 at screening to be eligible for the study.
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A caregiver who is reliable and attends the subject at least an average of 3 hours or more per day for 3 or more days per week, and who is willing to accompany the subject to the clinic visits and complete the caregiver questions, is needed.
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by National Institute on Aging-Alzheimer's Disease Centers (NIA-ADC) or Mayo Clinic Arizona Alzheimer's Disease Research Center (MCADRC) There is a cognitive deficit that meets the diagnostic criteria for probable Alzheimer's dementia and it must be confirmed by the National Institute on Aging-Alzheimer's Disease Centers or the Mayo Clinic Arizona Alzheimer's Disease Research Center.
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were randomized to receive either placebo or 20 mg/day of memantine for 12 weeks
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You are 55 to 85 years of age.\n

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~slopes will be estimated by using sib data at week 0, 5, 9, 13, 15, 20, 24, and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and slopes will be estimated by using sib data at week 0, 5, 9, 13, 15, 20, 24, and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: Severe Impairment Battery total score
Safety: Treatment-emergent adverse events and serious adverse events for all randomized subjects who received any study medication
Secondary outcome measures
SIB total scores from baseline at Weeks 5, 9, 15, 20 and 24 for subjects with baseline Mini Mental State Exam version 2 (MMSE-2) scores of 10-14 and 15-18
SIB total scores from baseline at Weeks 5, 9,15, 20 and 24
SIB trends over time
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Bryostatin 1Active Control1 Intervention
20ug Bryostatin will be administered over 45 minutes IV. The course of treatment will include 7 doses over the first 12 weeks, followed by a second identical treatment period beginning 30 days after completion of the first treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered over 45 minutes IV. The course of treatment will include 7 doses over the first 12 weeks, followed by a second identical treatment period beginning 30 days after completion of the first treatment period.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,681 Previous Clinical Trials
6,930,097 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,656 Previous Clinical Trials
28,004,083 Total Patients Enrolled
Neurotrope Bioscience, Inc.Lead Sponsor
3 Previous Clinical Trials
264 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
JEM Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
~26 spots leftby Mar 2025