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CNS Stimulant

Group A: 2 tabs of 18 mg Concerta daily for Dementia

Phase 3
Waitlist Available
Led By Ardis A Moe, M.D.
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks of drug exposure
Awards & highlights

Study Summary

This study is being done to see if a drug called long acting methylphenidate (Concerta) is safe and effective as a treatment for problems with mental function in adults infected with HIV. A subset of patients with HIV-associated memory loss have a defect in the speed with which they learn and process information. Methylphenidate drugs, such as Ritalin or Concerta, have been shown on tests to improve the ability to rapidly absorb information; these tests are called "reaction time tests". These drugs are already FDA-approved to treat Attention Deficit Disorders: ADD or ADHD. At baseline, all subjects get tests of memory and brain function; then they are split into two groups. One group on this study will receive Concerta for 2 weeks, and a second group will receive a placebo x 2 weeks. After that period both groups will receive memory and other tests of brain function, and then the groups will switch. The first group will receive placebo and the second will receive Concerta x 2 weeks, followed by more memory and neurological tests. After that all subjects will have the option to receive Concerta for free for 8 more weeks. At the last visit all subjects get memory and brain tests again.

Eligible Conditions
  • Dementia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks of drug exposure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks of drug exposure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in rate of reaction time as measured by neuropsychological testing
Secondary outcome measures
Number of Subjects with Adverse Events as Measures of Safety and Tolerability of Concerta in HIV infected adults

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group A: 2 tabs of 18 mg Concerta dailyActive Control1 Intervention
20 subjects to receive active study drug in a blinded fashion x 2 weeks, then washout x 2 weeks, then cross over to receive matched placebo x 2 weeks.
Group II: Group B: Matched placebo, 2 tabs dailyPlacebo Group1 Intervention
Group B to receive matched placebo x 2 weeks, then washout x 2 weeks, then cross over to receive active drug in a blinded fashion x 2 weeks.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,278,162 Total Patients Enrolled
13 Trials studying Dementia
7,310 Patients Enrolled for Dementia
Ardis A Moe, M.D.Principal InvestigatorUCLA Center for AIDS Research and Educationi

Frequently Asked Questions

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~3 spots leftby Apr 2025