Cognitive DisordersPhase 2NCT00002154
A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
A Phase 2 study testing Thioctic acid and Selegiline hydrochloride in people with Cognitive Disorders and HIV Infections, run by The Dana Foundation at 3 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Disorders, HIV Infections
- What is being tested?
- Thioctic acid and Selegiline hydrochloride
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Hosp
Baltimore, Maryland, 212876965
Columbia Univ
New York, New York, 10032
Univ of Rochester Med Ctr
Rochester, New York, 14642
About this study
Official title: Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia
The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).
Read the detailed 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.
- Conditions
- Cognitive Disorders, HIV Infections
- Being tested
- Thioctic acid, Selegiline hydrochloride
- Keywords
- Drug Therapy, Combination, Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thioctic Acid, Selegiline
- Medical subject headings
- Cognitive Dysfunction, HIV Infections, Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thioctic acidDrug
Selegiline hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- The Dana Foundation
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002154
- Sponsor's protocol ID
- 250A
- Other IDs
- 03-D95
- Status last verified
- Mar 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia
- ClinicalTrials.gov ID
- NCT00002154
- Acronym / sponsor ID
- 250A
- Conditions
- Cognitive Disorders, HIV Infections
- Keywords
- Drug Therapy, Combination, Cognition Disorders, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Thioctic Acid, Selegiline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- The Dana FoundationUniversity, hospital or other
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry.
- 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.
Key exclusion criteria (16 listed)
- 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.
- Chemotherapy for malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thioctic acid | Drug | – |
| Selegiline hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thioctic acid and Selegiline hydrochloride in people with Cognitive Disorders and HIV Infections, run by The Dana Foundation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.