Phase 2
Completed N=20
Safety Study of R(+)Pramipexole to Treat Early Alzheimer's Disease
Source: ClinicalTrials.gov NCT01388478 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Number of Patients With Adverse Events — 18 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events |
18 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01388478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.