Search / Trial NCT00002154

A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia

Launched by THE DANA FOUNDATION · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Drug Therapy, Combination Cognition Disorders Acquired Immunodeficiency Syndrome Aids Related Complex Thioctic Acid Selegiline

Description

Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • * Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry.
  • Patients must have:
  • * HIV seropositivity.
  • * Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down).
  • * No active opportunistic CNS infection.
  • * Ability to give informed consent.
  • Prior Medication:
  • Allowed:
  • * Prior antiretrovirals provided dose has been stable for at least the past 6 weeks.
  • * Prior thioctic acid or deprenyl.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • * Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance.
  • * CNS neoplasms.
  • * Any other clinically significant condition or laboratory abnormality that would preclude participation on study.
  • * Current participation in other drug studies.
  • Concurrent Medication:
  • Excluded:
  • * Chemotherapy for malignancy.
  • Patients with the following prior conditions are excluded:
  • * History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease.
  • * Prior participation in this study.
  • * History of adverse reaction/allergy to thioctic acid or deprenyl.
  • Prior Medication:
  • Excluded:
  • * Other investigational drugs within 30 days prior to study entry.

About The Dana Foundation

The Dana Foundation is a prominent philanthropic organization dedicated to advancing brain research through innovative funding, education, and outreach initiatives. With a focus on neuroscience and brain health, the foundation supports clinical trials and research projects that aim to enhance our understanding of brain disorders, promote effective treatments, and improve patient outcomes. By fostering collaboration among researchers, clinicians, and the public, the Dana Foundation plays a critical role in translating scientific discoveries into practical applications, ultimately contributing to the betterment of neurological health worldwide.

Locations

Baltimore, Maryland, United States

Rochester, New York, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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