TTP488 Efficacy & Safety Study in Mild Alzheimer’s (STEADFAST)
Research type
Research Study
Full title
Randomized, Double-Blind, Placebo Controlled, Multi-Center Registration Trial to Evaluate the Efficacy and Safety of TTP488 in Patients with Mild Alzheimer's Disease receiving Acetylcholinesterase Inhibitors and/or Memantine
IRAS ID
205067
Contact name
Ashley Baldwin
Contact email
Sponsor organisation
vTv Therapeutics LLC
Eudract number
2016-002005-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
68,445, US IND Number
Duration of Study in the UK
2 years, 3 months, days
Research summary
This is a randomised, double-blind, placebo controlled Phase 3 study to evaluate the efficacy and safety of azeliragon (investigational product) in patients with mild Alzheimer's Disease receiving Acetylcholinesterase inhibitors and/or memantine
About 800 people, aged 50 years or over, who have been diagnosed with mild Alzheimer's Disease are anticipated to take part in this study. Participants are required to be on a stable dose of standard of care therapy for at least three months prior to the baseline visit for this study.
There will be two treatment groups for this study, one group will receive Azeliragon (5mg/day) plus standard of care, and the other group will receive placebo plus standard of care. Participants will be randomly assigned to one of these two groups on a 1:1 basis.
Participants will take part in this study for up to 23 months.The study has three phases:
1) Screening phase, for up to two months;
2) Treatment phase, for 18 months;
3) Follow up Phase, 3 months.Participants will be asked to make at least 9 clinic visits for this study, in total.
Each participant must have a reliable and capable support person/caregiver who interacts with them regularly (10 hours or more each week either by phone or face to face), and who will be available to attend all clinic visits in person.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0363
Date of REC Opinion
19 Aug 2016
REC opinion
Further Information Favourable Opinion