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

NCT01388478 | Completed Phase 2 Results DMC

• 2 other identifiers: VCU-KU-ADDF-201120101202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Alzheimer's Disease

Keywords

Safety; Tolerability; R(+)Pramipexole; Alzheimer's

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events

  Labwork will be performed every two months. There will be frequent contact with subjects to assess for adverse events.

  6 months

Other Outcomes (3)

• Effects on Cognitive Performance

  Baseline and then 6 months thereafter

• Changes in Cerebral Glucose Metabolism

  Baseline and at 24 weeks after taking drug

• Reduction of Oxidative Stress

  Baseline and at 24 weeks after taking study drug

Study Arms (1)

R(+)pramipexole

EXPERIMENTAL

Each study participant will be given the active study drug, R-pramipexole. There is no placebo arm.

Drug: R-pramipexole

Interventions

R-pramipexole DRUG

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.

Also known as: Dexpramipexole

R(+)pramipexole

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent provided by the participant or the participant's legally acceptable representative
• Age 55 years or older
• Possible/probable Alzheimer's Disease (AD)
• Community dwelling with a caregiver able and willing to accompany the participant on all visits, if necessary. Caregiver must visit with the subject \>5 times per week.
• Rosen Modified Hachinski score of 4 or less
• Imaging Study (CT or MRI) compatible with AD or age-related changes (absence of significant abnormalities that may explain cognitive decline, such as multiple lacunar infarcts or a single prior infarct \>1 cubic cm, microhemorrhages or evidence of a prior hemorrhage \> 1 cubic cm, evidence of cerebral contusion encephalomalacia, aneurysm, vascular malformation, or space occupying lesion such as an arachnoid cyst or brain tumor).
• Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments

You may not qualify if:

• Significant neurological disease, other than AD, that may affect cognition
• Current clinically-significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.
• History of clinically-evident stroke
• Clinically-significant infection within the last 30 days
• Myocardial infarction or symptoms of active coronary artery disease (e.g., angina) in the last two years.
• Uncontrolled hypertension within the last 6 months.
• History of cancer within the last 5 years (except non-metastatic basal or squamous cell carcinoma)
• History of drug or alcohol abuse as defined by DSM-IV criteria within the last 2 years
• Insulin dependent diabetes mellitus
• Significant pain or musculoskeletal disorder that would prohibit participation in metabolic testing

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of Kansas: collaborator
• Alzheimer's Drug Discovery Foundation: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Dexpramipexole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Jeffrey Burns, M.D., M.S.
• Organization: University of Kansas Medical Center

KUAMP@kumc.edu

913-588-0555

Study Officials

• James P. Bennett, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Jeffrey M Burns, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 6, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)