Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088387
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-07-23
Brief Title:
Effect of Lithium and Divalproex in Alzheimers Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Glycogen Synthetase Kinase 3 GSK-3 Inhibition in Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Alzheimers 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 Alzheimers disease
Patients with Alzheimers 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 weeks 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
Patients with Alzheimers 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 weeks 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
Detailed Description:
The overall objective of this study is to examine the acute effects of lithium alone andor in combination with divalproex on surrogate measures of neuroprotective activity in patients with Alzheimers disease It is hypothesized that at safe and tolerable doses these drugs will inhibit glycogen synthase kinase-3 activity and reduce the phosphorylated tau epitopes threonine-181 and threonine-231 implicated in the pathogenesis of this disorder In this proof-of-principle study efficacy on reducing tau phosphorylated epitopes will be assessed through cerebrospinal fluid CSF measurements Safety will be monitored by means of frequent clinical evaluations and laboratory tests
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0243 | None | None | None |