Alzheimer's disease Nervous System Diseases Alzheimer's disease
Conditions
Interventions
Following enrolment visit and baseline assessments, eligible patients were randomised to receive lithium sulphate (Lithionit®) or placebo (randomised 1:1), and entered into a titration phase of six we
Sponsors
AstraZeneca (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline and the end of treatment (10 weeks): 1. Change in GSK-3 activity in lymphocytes 2. Change in p-tau181 and p-tau231 in CSF | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline and the end of treatment (10 weeks): 1. Change in beta-amyloid (1-42) in CSF and blood 2. Change in tau in CSF 3. Change in cognitive function as measured by cognitive subscore of the Alzheimer's Disease Assessment Scale (ADAScog) and Neuropsychiatric Inventory (NPI) 4. To monitor safety and tolerability | — |
Countries
Germany
Outcome results
None listed