This study will evaluate the safety and potential benefit of Dimebon as compared to placebo in patients with mild to moderate Alzheimer's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
183
Mental Health Research Center of Russian Academy of Medical Sciences
Moscow, Moscow, Russia
Alzheimer's Disease Assessment Scale - cognitive subscale
Time frame: 26 weeks
Clinical Global Impression of Change
Time frame: 26 weeks
Safety Assessed By Number of Participants With Adverse Events
Adverse events will be assessed through physical examinations, electrocardiograms, and clinical laboratory data (chemistry panel, complete blood count (CBC) with differential, and urinalysis). The incidence of adverse events will be summarized by severity and relationship to study treatment.
Time frame: 26 weeks
Pharmacokinetic (PK) parameter of Dimebon: Cmax
Cmax: Maximum concentration
Time frame: Week 1, 2, 6, 12, 18, 24. Blood PK samples will be obtained pre-dose and 1 hour post-dose for each timepoint.
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