RO4602522
DrugParticipants will receive RO4602522 orally once daily for 12 months.
NCT Number: NCT01677754
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.
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Notify Me50 year–90 year
All sexes
Interventional
Phase 2
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive RO4602522 orally once daily for 12 months.
Participants will receive placebo for RO4602522 orally once daily for 12 months.
Stable dose as background medication
Stable dose as background medication in combination with AChEIs
Stable dose as background medication
Stable dose as background medication
Time frame: Baseline, Month 12
Time frame: Baseline, Month 12
Time frame: Baseline, Month 12
Time frame: Baseline, Month 12
Time frame: Baseline to Month 12
Time frame: Baseline, Month 12
Time frame: Baseline, Month 12
Time frame: Baseline to Month 12
Time frame: Baseline, Month 12
Time frame: Baseline, Month 12
Time frame: Baseline up to 13 months
Time frame: Baseline; Months 6, and 12
Time frame: Baseline, Months 6, and 12
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)
Time frame: Baseline to 13 Months
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
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
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
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
Hoffmann-La Roche
Industry
A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to Background Alzheimer's Disease Therapy in Patients With Moderate Severity Alzheimer's Disease
Acronym: MAyflOwer RoAD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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