MedTrace Logo

Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease

NCT01388478 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-12

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

R-pramipexole

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.

Sponsors & Collaborators

  • University of Kansas

    collaborator OTHER

  • Alzheimer's Drug Discovery Foundation

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • James P. Bennett, MD, PhD · Virginia Commonwealth University

  • Jeffrey M Burns, MD · University of Kansas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388478 on ClinicalTrials.gov