Preliminary Evaluation of Lithium in Mild Cognitive Impairment
Research type
Research Study
Full title
Preliminary Evaluation of Lithium as a GSK-3 inhibitor in Mild Cognitive Impairment
IRAS ID
198590
Contact name
Ashleigh C Duthie
Contact email
Sponsor organisation
NHS Tayside
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
The project is designed to generate critical information to assess the feasibility and inform the protocol for a full trial on lithium prevention of the onset of Alzheimer's disease (AD).
Lithium has been used for decades to treat Bipolar Affective Disorder. Some of its therapeutic benefits are through the inhibition of an enzyme called Glycogen Synthase Kinase-3 (GSK3). GSK3 activity is associated with the development of several aspects of AD, therefore lithium may be a potential treatment option which could help to prevent AD. As an important step towards designing a clinical trial to investigate this potential, we aim to establish the minimum dose of lithium needed to block GSK3 in people with Mild Cognitive Impairment (MCI), a high-risk condition for progression to AD. We will check whether GSK3 activity is altered in MCI and monitor lithium regulation of GSK3 measures, often known as biomarkers, in this population. At the same time we will investigate how GSK3 measured in blood relates to GSK3 activity in the brain in a small animal study. In further preparation for a future large scale trial, we will generate technical data to allow us to develop the technique of using Magnetic Resonance Spectroscopy (MRS) as a biomarker to detect the earliest brain changes of AD.
Recruitment will be shared between the two sites for this study, Dundee and Oxford. The study will involve 12 patients with MCI and 12 controls, who will be asked for two sets of blood tests, and 20 patients with MCI who consent to take Lithium who will be asked for blood tests at regular intervals. For all participants the study period is 12 weeks.REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0006
Date of REC Opinion
10 Feb 2016
REC opinion
Further Information Favourable Opinion