OLE study: Safety & efficacy - Azeliragon in mild Alzheimer's patients
Research type
Research Study
Full title
OPEN LABEL EXTENSION STUDY FOR CONTINUED SAFETY AND EFFICACY EVALUATION OF AZELIRAGON IN PATIENTS WITH MILD ALZHEIMER'S DISEASE
IRAS ID
235989
Contact name
Ashley Baldwin
Contact email
Sponsor organisation
vTv Therapeutics LLC
Eudract number
2017-004065-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
68,445, US IND Number; 9427-T1538-21C, Health Canada File Number:
Duration of Study in the UK
2 years, 4 months, 11 days
Research summary
vTv Therapeutics has begun a research study of an investigational drug called azeliragon (TTP488) as a possible treatment for mild Alzheimer’s disease.
Alzheimer’s disease is a disorder characterised by progressive loss of memory, thinking, and behaviour. An earlier study in patients having mild to moderate Alzheimer’s disease has demonstrated more pronounced benefit of treatment with azeliragon plus standard of care when compared to standard of care treatment alone. The main purpose of this study is offer azeliragon to those participants who have completed the TTP488-301 (STEADFAST) study and to continue to learn how well azeliragon works and how safe this study medication is in participants with Alzheimer’s disease.
It is an open label study lasting for approximately 2 years. This study will be carried out in approximately 115 centers in 7 countries (United States, Canada, United Kingdom, South Africa, New Zealand, Australia and Ireland). Up to 800 people with Alzheimer’s disease, who have completed the TTP488-301 (STEADFAST) study will be invited to join this study. Each research participant must have one caregiver willing to assist, who will be asked to sign a separate consent outlining their role.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0047
Date of REC Opinion
19 Mar 2018
REC opinion
Further Information Favourable Opinion