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A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy

NCT01677754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2017-05-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

RO4602522

Participants will receive RO4602522 orally once daily for 12 months.

DRUG

Placebo

Participants will receive placebo for RO4602522 orally once daily for 12 months.

DRUG

Donepezil

Stable dose as background medication

DRUG

Memantine

Stable dose as background medication in combination with AChEIs

DRUG

Rivastigmine

Stable dose as background medication

DRUG

Galantamine

Stable dose as background medication

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-24
Primary Completion
2015-06-12
Completion
2015-06-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677754 on ClinicalTrials.gov