Back to Alzheimers Disease
This trial is complete. It is no longer accepting participants.

NCT00088387

NCT00088387
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You are between 40 and 90 years old (inclusive).
  • You have been diagnosed with Alzheimer's disease and are able to give your own consent to participate (you will be assessed for this ability).
  • Your score on a test that helps rule out certain stroke-related memory conditions (called the modified Hachinski Ischemia Score) must be below 4 (confirm with trial site).
  • You have had a brain MRI scan within the last 15 months that is consistent with an Alzheimer's disease diagnosis.
  • You and/or your caregiver are willing to follow the study rules and sign a written consent form.

Who may not be able to join:

  • You have a medical condition that could put you at unreasonable risk by participating.
  • You have significant abnormal blood or lab test results that would make it unsafe to take the study medications (lithium and divalproex).
  • You are currently taking, or have recently taken, certain medications that are not allowed in this study, including some antidepressants, anti-seizure drugs, certain antibiotics, certain blood pressure or pain medications, certain diuretics (water pills), certain heart or blood-thinning medications, or other drugs that could interact with the study medications (confirm with trial site for the full list).
  • You are a woman of childbearing age who has not been using reliable contraception for at least the last 30 days, or who is unwilling to continue using contraception during the study, and who has not gone through menopause (at least one year without a period).
  • You are pregnant or breastfeeding.
  • You have taken part in another clinical drug trial within the last 30 days.
  • You have an active substance (drug or alcohol) abuse problem, or another condition that the study doctors believe would make it unsafe or difficult for you to participate.
  • You have a known allergy or sensitivity to lithium or divalproex.
  • You are unable to swallow tablets or follow a medication schedule.
  • You do not have a caregiver who is able to support you during the study.
  • You or your caregiver are unwilling to sign the consent form or follow the study requirements.
  • You are unwilling to have a lumbar puncture (a procedure, sometimes called a spinal tap, where a small amount of fluid is taken from around the spine).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Registry
clinicaltrials_gov
Start date
1 July 2004

Where this trial is recruiting

🇺🇸 United States

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov