Phase 2
Completed N=50
Rasagiline Rescue in Alzheimer's Disease Clinical Trial
Source: ClinicalTrials.gov NCT02359552 ↗Enrolled (actual)
50
Serious AEs
10.0%
Results posted
Oct 2020
Primary outcomePrimary: Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET). — -0.032; -0.011; -0.020; -0.003 SUVR
Summary
This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of concept three-site study, to evaluate the effect of Rasagiline in the regional brain metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Regional Glucose Metabolism Between Week 24 and Baseline as Measured by 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET). |
-0.032; -0.011; -0.020; -0.003; -0.016; -0.003 | — |
| SECONDARY Change in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale - Cognitive 11) Score |
2.76; 1.81 | — |
| SECONDARY Change in MMSE (Mini Mental Status Examination) Score |
-1.14; -0.65 | — |
| SECONDARY Change in ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) Score |
-3.23; -3.75 | — |
| SECONDARY Change in NPI (Neuropsychiatric Inventory) Score |
2; 0.2 | — |
| SECONDARY Change in Digit Span |
-1.18; -0.29 | — |
| SECONDARY Change in COWAT (Controlled Oral Word Association Test) Score |
-1.09; 0.62 | — |
| SECONDARY Change in QoL-AD (Quality of Life - Alzheimer's Disease) Score |
-1.95; 1.11 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females 50 to 90 of age inclusive.
- Diagnosis of probable AD (NINCDS-ADRDA criteria)
- Positive fluoro-deoxyglucose PET ([18F]-FDG PET) scan compatible with AD as determined by the ADM Diagnostics LLC (ADMdx) Criteria at screening
- Mini Mental Status Exam = 12 - 22 (inclusive)
- Must have a study partner who is able and willing to comply with all required study procedures.
- Have at least eight years of education and should have previously (in pre-AD condition) been capable of reading, writing, and communicating effectively with others in English.
- If receiving therapy with a cholinesterase inhibitor and/or memantine, the dose of these agents has been stable for at least 3 months prior to screening
Exclusion Criteria
- Any non-AD neurological disease
- MRI findings indication of a non-AD diagnosis
- Screening laboratory studies that are 1.5 times above or below the highest and lowest range of normal for each test respectively
- History of melanoma; history of malignancy within the past five years with the exception of basal cell or squamous cell cancer, in-situ cervical cancer, or localized prostate cancer
Data sourced from ClinicalTrials.gov (NCT02359552). 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.