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 May 14, 2025
Completed
Keywords
ClinConnect Summary
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Rochester, New York, United States
New York, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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