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

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

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.

Buntanetap inhibits translation of all the above four neurotoxic proteins, thus is well positioned to treat both diseases, which is an advantage compared to removing a single neurotoxic protein alone. In a double-blind, placebo-controlled, multi-center phase 2, study we enrolled 14 early AD and 54 early PD participants who were treated for 25 days with buntanetap or placebo. Buntanetap was safe and well tolerated. Biomarker data indicated a trend in lowering levels of neurotoxic proteins and inflammatory factors and improving axonal integrity and synaptic function in both AD and PD cohorts, confirming target and pathway engagement of buntanetap. Psychometric tests showed statistically significant improvements in ADAS-Cog11 and WAIS coding in AD patients and MDS-UPDRS and WAIS coding in PD patients. These findings support the hypothesis that lowering levels of neurotoxic aggregating proteins leads to stabilization and improvement in cognition and motor function.
Please look us up at ClinicalTrials.gov

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