A Study in Healthy Elderly People of a Drug that May Improve Memory.V1
Research type
Research Study
Full title
Interventional, randomised, double-blind, parallel-group, placebo-controlled, Phase 1, exploratory study investigating the effects of HTL0009936 on cognition and BOLD fMRI signals in healthy elderly subjects
IRAS ID
182093
Contact name
John Francis William Deakin
Contact email
Sponsor organisation
Heptares Therapeutics Limited
Eudract number
2015-002490-38
Duration of Study in the UK
0 years, 11 months, 27 days
Research summary
The study will explore whether a single, infused dose of HTL0009936, compared to placebo, leads to changes in neural activity in the brains of healthy elderly people whilst they are performing cognitive tasks. The study will focus particularly on those areas of the brain associated with spatial and working memory, learning and executive functioning. Neural activity will be measured using functional Magnetic Resonance Imaging (fMRI) of the brain. Electrical activity of the brain will be measured using Electroencephalography (EEG) and event-related potential (ERP). The ERP measures the brain response that is the direct result of listening to a series of sounds.
Healthy volunteers will attend a screening visit to determine whether they are eligible to enter the study. This will be followed by a baseline visit at which they will complete a number of questionnaires and scales, will practise the cognitive tasks that will later be completed in the fMRI scanner during the assessment visit and EEG measurements will be taken. Eligible participants will be randomised to receive either placebo, low-dose HTL0009936 or high-dose HTL0009936 infusion. They will return to the study site for an Assessment Visit and will be given an infusion of study drug lasting around 3.5 hours. Prior to and during the infusion period, participants will perform the ERP test (on two occasions) and then will spend around 1.5 hours in the fMRI scanner completing computer-based cognitive tasks. They will be discharged from the study site approximately 6 hours after the end of the infusion. Participants will return for a follow-up visit to check their general health. The study will last for a maximum of 10 weeks for each participant.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/1316
Date of REC Opinion
16 Sep 2015
REC opinion
Further Information Favourable Opinion