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.
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.