A randomised, single-blinded, placebo-controlled, multicentre study to investigate the pharmacodynamic effects of lithium on glycogen synthase kinase-3 (GSK-3) activity in patients with Alzheimer's disease

Completed

• Conditions: Alzheimer's disease; Nervous System Diseases

• Registration Number: ISRCTN72046462
• Lead Sponsor: AstraZeneca (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Provision of informed consent
2. Female, without child bearing potential (post-menopausal for at least one year or surgically sterile) or male, aged 50 - 85 years
3. Clinical diagnosis of mild Alzheimer's disease
4. Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for primary degenerative dementia of the Alzheimer's type
5. National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for Alzheimer's disease
6. Stable dose of cholinesterase inhibitors (ChEI) for at least six months or no prior treatment with ChEI. Limited treatment periods with ChEI such as days or weeks after which treatment was stopped, not regarded as having any effects on the disease.
7. Willingness and ability to complete all study-related procedures and to understand patient information

Exclusion Criteria

1. Any other clinically significant condition or laboratory abnormality that may interfere with the patient's ability to participate in the study or the study results, as judged by the investigator
2. Electrocardiogram (ECG) changes and/or signs indicative of significant cardiovascular disease, or other conditions in which lithium treatment is contraindicated, as judged by the investigator
3. Untreated hypothyroidism
4. Concomitant use of valproic acid, memantine, neuroleptics, coumarin, anticoagulants, or non-steroidal non-inflammatory drugs (NSAIDs)
5. Salt-restricted diet
6. Clinically significant liver disease or an elevation in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin of 1.5 times the upper limit of the reference range
7. Known or suspected drug or alcohol abuse
8. Contraindications as detailed in the country-specific prescribing information for lithium
9. Participation in another drug trial within four weeks prior enrolment into this study or longer in accordance with local requirements
10. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational sites)
11. Previous enrolment or randomisation of treatment in the present study

Study & Design

• Study Type: Interventional
• Study Design: Not specified