CompletedPhase 2Results posted

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

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

Lead sponsor

Virginia Commonwealth University

Asset

R-pramipexole

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•Adverse Events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Other grant20101202Alzheimer's Drug Discovery Foundation

NCT IDNCT01388478

Org study IDVCU-KU-ADDF-2011

Timeline

Milestones

Study start2011-07 (month precision)

Study first posted2011-07-06estimated

Primary completion2014-01actual (month precision)

Study completion2014-04actual (month precision)

Last update posted2021-10-12actual

Results first posted2021-10-12actual

Assets

Drug assets

R-pramipexole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Safety / tolerability / PK

Global cognition

2 endpoints

Other/protocol endpoint

Effects on Cognitive Performance

Time frame:Baseline and then 6 months thereafter

categorical status, descriptive

Other_pre_specified/registry result

Effects on Cognitive Performance

Time frame:Baseline and then 6 months thereafter

categorical status, descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Patients With Adverse Events

Time frame:6 months

event count, event

Primary/registry result

Number of Patients With Adverse Events

Time frame:6 months

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
R(+)Pramipexolen=20 Participants	18	-

Other (unclassified)

4 endpoints

Other/protocol endpoint/low confidence

Changes in Cerebral Glucose Metabolism

Time frame:Baseline and at 24 weeks after taking drug

ratio, descriptive

Other/protocol endpoint/low confidence

Reduction of Oxidative Stress

Time frame:Baseline and at 24 weeks after taking study drug

descriptive

Other_pre_specified/registry result/low confidence

Changes in Cerebral Glucose Metabolism

Time frame:Baseline and at 24 weeks after taking drug

ratio, descriptive

Other_pre_specified/registry result/low confidence

Reduction of Oxidative Stress

Time frame:Baseline and at 24 weeks after taking study drug

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.