Evaluation of Brain and Cognitive Changes in Older Adults With MCI Taking Lithium to Prevent Alzheimer Type Dementia

PRO17030527

Alzheimer's disease (AD) is the most common cause of dementia in adults 65 years and older. AD leads to a complete loss of memory and independent function, and presently there is no cure. Many studies suggest that lithium treatment may delay dementia onset or slow its progression. However, more research is needed to understand the extent of its anti-dementia properties if it will be deployed broadly in the general population. This study will examine whether lithium has anti-dementia properties in older adults who have mild cognitive impairment and are at risk of becoming demented.

2017-09-01

2024-08-31

2024-08-31

Active (not recruiting)

Early phase I

80

Inclusion Criteria: 1. 60 years or older 2. Diagnosis of Mild Cognitive Impairment Exclusion Criteria: 1. Major psychiatric illness (mild psychiatric illness may be included) 2. Major neurologic illness (e.g., multiple sclerosis) 3. Contraindication to lithium (e.g., renal insufficiency) 4. Unable to complete neuropsychological testing due to non-remediable impairment (e.g., blindness)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Longitudinal, randomized, double-blind, placebo-controlled experimental trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Participants, investigators (who will also be prescribers/care providers), and both clinical and cognitive raters will be blind to treatment. A non-blind physician not providing care or ratings will receive real and generate false blood levels to communicate to other investigators for the purpose of titration of the lithium/placebo. Measures for emergency unblinding will be available as well for safety.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

2024-05-09