This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in participants with moderate severity Alzheimer's disease. Participants who are taking background therapy of acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4 months before screening will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
542
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12
Time frame: Baseline, Month 12
Percentage of Participants Achieving Response, Defined as an Increase From Baseline of Less Than or Equal to (<=) 4 Points in ADAS-Cog-11
Time frame: Baseline, Month 12
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Scale Score at Month 12
Time frame: Baseline, Month 12
Change From Baseline in Behavioral Pathology in Alzheimer's Disease Frequency-Weighted Severity Scale (BEHAVE-AD-FW) Score at Month 12
Time frame: Baseline, Month 12
Percentage of Participants With Worsening in BEHAVE-AD-FW Score
Time frame: Baseline to Month 12
Change From Baseline in Apathy Evaluation Scale (AES) Score at 12 months
Time frame: Baseline, Month 12
Change From Baseline in Alzheimer's Disease Cooperative Study Clinician Global Impression of Change (ADCS-CGIC) Scale Score at 12 months
Time frame: Baseline, Month 12
Percentage of Participants With Worsening in ADCS-CGIC Score
Time frame: Baseline to Month 12
Change From Baseline in Global Deterioration Scale (GDS) Score at 12 months
Time frame: Baseline, Month 12
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at 12 months
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Stable dose as background medication in combination with AChEIs
Stable dose as background medication
Stable dose as background medication
Advanced Research Center, Inc.;In-Patient Unit
Anaheim, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Torrance Clinical Research
Lomita, California, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Neurological Research Inst
Santa Monica, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
...and 132 more locations
Time frame: Baseline, Month 12
Percentage of Participants with Adverse Events
Time frame: Baseline up to 13 months
Percentage of Participants with Change in Lens Opacity Grading
Time frame: Baseline; Months 6, and 12
Percentage of Participants with Abnormal Visual Acuity Test Results
Time frame: Baseline, Months 6, and 12
Change From Baseline in Michigan Neuropathy Screening Instrument Score
Time frame: Baseline, Weeks 8, 18, 30, 44, 52, and at the last follow-up visit (12 weeks after last dose, up to 64 weeks)
Percentage of Participants Receiving Concomitant Medications
Time frame: Baseline to 13 Months
Apparent Total Clearance of the Drug From Plasma After Administration of RO4602522
Time frame: Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
Apparent Volume of Distribution at Steady State after Administration of RO4602522
Time frame: Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
Area Under the Plasma Concentration-Time Curve of RO4602522
Time frame: Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
Maximum Plasma Concentration of RO4602522
Time frame: Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364