Join Us in Transforming Alzheimer's Treatment

A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD

Started: Feb 4, 2025
Last Updated: Aug 5, 2025
Status
Enrolling
Phase
3
Age
55 - 85 years
Enrollment Goal
760
Study Drug:
Buntanetap (formerly Posiphen)
Key Inclusions:
MMSE 21-28

Positive for plasma pTau217
Primary Endpoints:
ADAS-Cog13

ADCS-iADL
Clinicaltrials.gov ID:
NCT06709014

THE STUDY AIMS TO ANSWER:

1. Does buntanetap improve cognition as measured by ADAS-Cog13?

2. Does buntanetap improve function as measured by ADCS-iADL?

3. What medical issues do participants have, if any, when taking buntanetap?

TREATMENT

Participants will take buntanetap (30mg) or placebo every day for 18 months.

OTHER ENDPOINTS

In addition to primary endpoints, the study will also measure MMSE, CGI-S, CDR, and volumetric MRI (hippocampus and whole brain).

TIMELINE

The study will have a 6-month read-out to measure symptomatic improvement and a 18-month read-out to measure potential disease-modifying response.

Find more information at ClinicalTrials.gov

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IRB approved Alzheimer Study Flyer: Buntanetap in Treating Alzheimer’s and Parkinson’s Disease   

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The data from our phase 2 study in Alzheimer’s and Parkinson’s patients was published in JPAD (Journal of Prevention of Alzheimer’s Disease) and we have attached the paper. Here is a summary of what we found and why we have progressed our drug into phase 3.
Buntanetap is an orally available small molecule that inhibits the translation of multiple neurotoxic aggregating proteins only under conditions where their translation is elevated – in sick nerve cells. Because it only affects these neurotoxic proteins when they are overexpressed, it restores their normal levels without affecting other proteins and restores homeostasis in the brain.
Both Alzheimer’s disease and Parkinson’s disease have been shown to have mixed pathology and mixed proteinopathy. All four neurotoxic aggregating proteins are present in the brain of Alzheimer and Parkinson patients – Aβ forms plaques, tau forms tangles, alpha-synuclein forms Lewy bodies, and TDP43 forms its aggregates.

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