Evaluation of Lithium as a Glycogen-Synthase-Kinase-3 (GSK-3) Inhibitor in Mild Cognitive Impairment

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The project is designed to generate critical information to design and justify a robust trial on lithium prevention of the onset of Alzheimer's disease (AD). Lithium exerts and inhibitory effect on Glycogen synthase kinase 3 (GSK-3) a brain biomarker of neuroprotection. The study consists of 3 phases:

1. Phase 1 investigates rats to establish a reliable method to measure brain biomarker activity levels from blood biomarker activity.

2. Phase 2 will determine whether the GSK3 enzyme activity is significantly different in subjects with MCI compared to normal individuals.

3. Phase 3 investigates patients with MCI taking lithium to establish the minimum lithium dose required to inhibit the activity of GSK-3.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Dundee
• Collaborator: University of Oxford
• Treatments: Lithium Carbonate

Criteria

Inclusion Criteria:

• diagnosis of Mild Cognitive Impairment (MCI).

Exclusion Criteria:

• Previous hypersensitivity to Lithium or other contraindication to Lithium carbonate Priadel (see most recent SmPC), Dementia Diabetes BMI <18 or >30 Rheumatoid Arthritis and Autoimmune Inflammatory disorders Currently taking NSAIDS Moderate renal failure (defined in BNF by gGFR <60 mL/minute/1.73m2) or severe Renal failure (defined in BNF by eGFR <29 mL/minute/1.73m2 Addison's disease, Brugada syndrome (or family history of Brugada syndrome), cardiac insufficiency, congestive cardiac failure, epilepsy, suicidality incapacity to consent currently prescribed lithium participation in another clinical trial of an Investigational Medicinal Product (IMP) in the last 28 days.

Uncontrolled serious concomitant physical illness