Lithium for Alzheimer's diseas

JRCT ID: jRCTs041180034

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer's disease
• Date of first enrollment: 07/07/2016
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Administration of lithium carbonate 300 micro gram/ day.

Outcome(s)

• Primary Outcome: A change total score of Alzheimer's disease assessment scale-cognitive subscale from baseline to endpoint.
• Secondary Outcome: A change total scores of Mini-Mental State Examination, Neuropsychiatric Inventory, and Disability Assessment for dementia from baseline to endpoint. Dropout rate for all reasons, dropout rate due to adverse event, Udvalg for kliniske undersogelser side effect scale, vital, hematological examination, blood biochemical examination.

Key inclusion & exclusion criteria

• Age minimum: none
• Age maximum: none
• Gender: Both

Include criteria

(1) The patient meets Diagnostic and Statistical Manual of Mental Disorders-V probable Alzheimer's disease.
(2) Clinical Dementia Rating scores are 1 or 2 points.

Exclude criteria

(1)Patients complicated of dementia other than Alzheimer's disease.
(2)Patients with a history of drug hypersensitivity to lithium.
(3)Lithium carbonate administration is contraindicated.
(4)Patients with severe complications and poor management.
(5)Patients with renal dysfunction (creatinine clearance <30).

Related Information

• Primary Sponsor: Iwata Nakao
• Source(s) of Monetary Support: Japan Society for the Promotion of Science
• Secondary ID(s): UMIN000020128