Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538066
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-08-06
Brief Title:
Bryostatin Treatment of Moderately Severe Alzheimers Disease
Sponsor:
Neurotrope Bioscience Inc
Organization:
Neurotrope Bioscience Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 2 Study Assessing Safety Tolerability and Long-term Efficacy of Bryostatin in the Treatment of Moderately Severe Alzheimers Disease Subjects Not Receiving Memantine Treatment
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety tolerability and long-term efficacy of bryostatin 1 hereafter referred to as bryostatin for the treatment of moderately severe Alzheimers disease AD
Detailed Description:
This is a randomized double-blind placebo-controlled Phase 2 study comparing bryostatin-1 to placebo for long-term efficacy in the treatment of moderately severe AD Mini Mental State Examination 2nd edition scores of 10-18 at baseline in the absence of memantine Eligible subjects will receive 7 doses of bryostatin iv 20μg or matching placebo during the first 12 weeks A second course of treatment consisting of 7 doses will begin 30 days after the final dose of the first treatment period Cognitive tests will be assessed at intervals during the study and 4 months after the final dose of study drug The primary endpoint is the total SIB score assessment obtained at Week 28 following completion of 2 courses of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44AG066366 | NIH | None | httpsreporternihgovquickSearchR44AG066366 |