At a glance
ClinicalIndex Comparison Record- ✓Age 65–90 years, inclusive
- ✓Cognitively intact (not demented by Hachinski Ischemic Index <4)
- ✓Stable medical condition ≥3 months, no clinically significant hepatic, renal, or hematologic abnormalities
- ✓Platelets >100,000
- ✕Significant neurologic disease (Parkinson's, stroke, brain tumor, multiple sclerosis, seizure disorder)
- ✕Major depression in past 12 months, schizophrenia, or recent alcohol/substance abuse
- ✕History of invasive cancer within 2 years (excluding non-melanoma skin cancer)
- ✕Contraindications to lumbar puncture (bleeding disorder, platelets <100,000, anticoagulant therapy, structural spinal abnormality, sepsis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety And Target Engagement Of Clu1 By Valproic Acid In Subjects With Intact Cognition: Proof Of Concept For The Development Of A Prevention Trial For Alzheimer's Disease
In Brief
A Early Phase 1 clinical trial evaluating Valproic Acid and Placebo for Alzheimer's Disease. Completed, enrolled 14 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety of administration and effects of valproic acid on clusterin expression in cognitively-intact, healthy, elderly subjects. Clusterin mutations have recently been identified as a risk factor for the development of Alzheimer's Disease and changes in clusterin expression are seen in the elderly who develop Alzheimer's disease irrespective of whether they carry these genetic mutations or not. Valproic acid may prevent or reverse these changes. Fourteen subjects with normal memory and thinking will participate in this study. Ten of these subjects will receive valproic acid and 4 will receive a "placebo" capsule with no active medicine. Participants will take study medication or placebo for 28 days and be followed for a total 35 days in this trial.
Study Details
Timeline
Interventions
generic valproic acid tablets packaged in placebo-matched capsules.
Placebo capsule without active study medication in identical capsules as experimental medicine.