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NCT01677754 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Alzheimers Disease, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
542
Enrollment target
20
Study locations

NCT01677754 is a Phase 2 study of Alzheimers Disease that has completed, run by Hoffmann-La Roche. The registered enrollment target is 542 participants, below the 4,058-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT01677754, a Phase 2 study of Alzheimers Disease, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
542 participants
Enrollment target
20
Study locations

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 Studied

Interventions

  • DRUG Placebo
  • DRUG Memantine
  • DRUG Rivastigmine
  • DRUG Donepezil
  • DRUG RO4602522

Study Locations (20)

Florida

  • Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
  • Meridien Research - Brooksville
  • Brain Matters Research, Inc. - Delray Beach
  • Neurologic Consultants, P.A. - Fort Lauderdale
  • Galiz Research, LLC - Hialeah
  • Miami Jewish Health Systems - Miami
  • Medical Research Group of Central Florida - Orange City
  • Compass Research East, LLC - Orlando
  • Comprehensive Clinical Development, Inc.- St. Petersburg, FL - St. Petersburg
  • Axiom Clinical Research of Florida - Tampa
  • Premiere Research Institute - West Palm Beach

California

  • Advanced Research Center, Inc.;In-Patient Unit - Anaheim
  • Neurology Center of North Orange County - Fullerton
  • Torrance Clinical Research - Lomita
  • Artemis Institute for Clinical Research, LLC - San Diego
  • Sharp Mesa Vista Hospital - San Diego
  • San Francisco Clinical Research Center - San Francisco
  • Neurological Research Inst - Santa Monica

Connecticut

  • Yale University School Of Medicine - New Haven
  • Research Center for Clinical Studies, Inc. - Norwalk

Trial Details

FieldValue
Enrollment Target 542 participants
Start Date 2012-10-24
Est. Completion 2015-06-12
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01677754

The ClinicalTrials.gov registry entry for NCT01677754 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 542 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,058-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (87% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT01677754 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01677754 about?

NCT01677754 is a clinical study titled "A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy". 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) alon...

What is the current status of trial NCT01677754?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 542 participants. The study started on 2012-10-24. Estimated completion is 2015-06-12.

What conditions does trial NCT01677754 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT01677754?

The interventions under investigation include: Placebo (DRUG), Memantine (DRUG), Rivastigmine (DRUG), Donepezil (DRUG), RO4602522 (DRUG).

Who is sponsoring clinical trial NCT01677754?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01677754 being conducted?

This trial has 20 study locations across California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.