Study of COR388 HCl in Subjects with Alzheimer’s Disease
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study of COR388 HCl in Subjects with Alzheimer’s Disease.
IRAS ID
263939
Contact name
Stuart Ratcliffe
Contact email
Sponsor organisation
Cortexyme Inc.
Eudract number
2019-000370-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
134303, IND
Duration of Study in the UK
1 years, 11 months, 25 days
Research summary
Summary of Research
The main purpose of the study is to assess the effect of the study drug (COR388 HCl) in patients with Alzheimers disease.
The safety and tolerability of the study drug will also be assessed.
The study will enroll approximately 573 generally healthy men and women aged between 55 and 80 years of age.Summary of results
Atuzaginstat did not demonstrate a treatment benefit compared to placebo for 40 mg BID and 80 mg BID doses for the co-primary and secondary efficacy endpoints in the ITT Population. Atuzaginstat did slow the decline in cognition and function in P. gingivalis positive subjects. The study findings provide support for a role of P. gingivalis as an upstream driver of the decline in cognition and function in patients with mild to moderate Alzheimer's disease.
This study provides valuable insight into our understanding of Alzheimer’s pathology and validates atuzaginstat, and therapeutics that target a reduction in P. gingivalis systemic infection as potential treatments to slow disease progression and severity in a specific sub-population of patients with Alzheimer’s disease. The evidence from this study advances our ability to identify patients and target treatment with atuzaginstat to improve patient outcomes. The data support that the 40 mg BID and 80 mg BID doses have similar efficacy in subjects positive for P. gingivalis infection.
Data from this study support the targeting of bacterial virulence factor Kgp as a therapeutic to specifically reduce oral and systemic infection by the bacterial pathogen P. gingivalis.
Atuzaginstat represents a new paradigm for modifying disease severity and the rate of cognitive decline in Alzheimer’s disease associated with P. gingivalis infection, similar to that used in other infection-related dementias (e.g.: HIV dementia, syphilis, neurological Lyme disease) and in other Alzheimer’s treatments (e.g.: Aduhelm (PET amyloid positive), donanemab (PET amyloid positive, intermediate tau levels).
There continues to be an unmet medical need for patients with mild to moderate Alzheimer’s disease. The data from COR388-010 support a positive risk/benefit profile for atuzaginstat in patients positive for P. gingivalis.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1279
Date of REC Opinion
24 Oct 2019
REC opinion
Further Information Favourable Opinion