Rasagiline Rescue in Alzheimer's Disease Clinical Trial (R2)

NeuroTherapia, Inc.

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Rasagiline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02359552

14-519

Details and patient eligibility

About

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).

Full description

The study consists of two phases: a 24 week double blind placebo controlled treatment period and a 4 week follow up period. Patients will be randomized in a 1: 1 ratio at baseline to receive either Rasagiline or matching placebo

The study drug will be given as 0.5 mg dose once daily for the 4 weeks, then increases to 1 mg daily for the next 20 weeks. A total of 50 subjects will be enrolled: 25 will receive Rasagiline and 25 will receive matching placebo for the 24-week treatment period.

Primary objective is to determine if exposure to 1 mg of Rasagiline daily is associated with improved regional brain metabolism in the treatment group compared to the placebo group in Alzheimer's Disease patients

Enrollment: 50 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment. Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).

Treatment:

Drug: Placebo

Rasagiline

Active Comparator group

Description:

Subjects will be randomized in 1:1 ratio to receive Rasagiline or the matching placebo 24-week double blind treatment. Subjects will take one 0.5 mg Rasagiline tablet or the matching placebo once a day on Baseline (Day 1) through Week 4. The dose will be titrated up to one 1 mg tablet or the matching placebo once a day starting on Week 5 until the Week 28 (end of treatment visit).

Treatment:

Drug: Rasagiline