CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
R-pramipexoledrug
Likely dose
R-pramipexole 5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01388478
NCT01388478Phase 2Completed
CompareCT.gov

Safety/Tolerability and Effects on Cognitive Impairment, Impaired Cerebral Cortical Metabolism and Oxidative Stress of R(+)Pramipexole Administered to Subjects With Early Alzheimer's Disease

Virginia Commonwealth University·interventional·Posted Jul 6, 2011·Updated Oct 12, 2021

In Brief

A Phase 2 clinical trial evaluating R-pramipexole for Alzheimer's Disease. Completed, enrolled 20 participants across 1 site.

Detailed Summary

By doing this study, researchers will examine the safety and tolerability of R-pramipexole in participants with Alzheimer's disease. This study will also examine the body and brain's response to the study drug by measuring the amount of injury to the cells (oxidative stress) in the blood and spinal fluid and brain imaging before and after treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
CollaboratorsUniversity of Kansas, Alzheimer's Drug Discovery Foundation

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 6, 2011
Enrollment StartJul 1, 2011
Primary CompletionJan 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.0 years ago

Interventions

R-pramipexoledrug

R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.