Effect of Lithium and Divalproex in Alzheimer's Disease
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
Summary
This study will examine the effect of the drugs lithium and divalproex (Depakote) on tau
proteins, a type of protein in the brain and spinal fluid that are altered in patients with
Alzheimer's disease. Both drugs are approved by the Food and Drug Administration to treat
mood disorders, and both have been shown in animal studies to decrease the amount of altered
tau protein. This study will determine whether lithium alone or in combination with
divalproex reduces the altered tau protein in the spinal fluid of patients with Alzheimer's
disease.
Patients with Alzheimer's disease who are between 40 and 90 years of age may be eligible for
this study. Candidates are screened with a medical history and physical examination,
neurologic and neuropsychological evaluation, blood and urine tests, electrocardiogram (EKG),
and, if needed, a magnetic resonance imaging (MRI) scan of the brain.
Participants undergo the following tests and procedures:
- Drug treatment: Patients take study drugs for 6 weeks.
- Weekly clinic visits: Patients come to the clinic once a week for a physical
examination, blood and urine tests, a review of drug side effects, and to receive the
next week's supply of medications.
- Lumbar puncture (spinal tap): Patients have a lumbar puncture at study weeks 2, 4, and 6
to measure various brain chemicals and tau proteins in the cerebrospinal fluid (CSF),
which bathes the brain and spinal cord. For this test, a local anesthetic is given and a
needle is inserted in the space between the bones in the lower back where the CSF
circulates below the spinal cord. A small amount of fluid is collected through the
needle.
- Follow-up visit: Two weeks after completing the study medication, patients return to the
clinic for a final evaluation, including a physical examination and blood and urine
tests.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)