A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

November 1, 2016 updated by: Hoffmann-La Roche

A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease

This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

389

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
      • Buenos Aires, Argentina, C1431FWO
      • Buenos Aires, Argentina, C1090AAH
      • Caba, Argentina, C1126AAB
  • Australia
    • New South Wales
      • Hornsby, New South Wales, Australia, 2077
    • Queensland
      • Chermside, Queensland, Australia, 4032
    • South Australia
      • Woodville, South Australia, Australia, 5011
  • Canada
    • Alberta
      • Medicine Hat, Alberta, Canada, T1A-4C2
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
      • London, Ontario, Canada, N6C 5J1
      • Ottawa, Ontario, Canada, K1N 5C8
      • Peterborough, Ontario, Canada, K9H 2P4
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M3B 2S7
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
      • Verdun, Quebec, Canada, H4H 1R3
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
  • France
      • Montpellier, France, 34295
      • Nice, France, 06003
      • St Herblain, France, 44800
      • Toulouse, France, 31059
  • Germany
      • Günzburg, Germany, 89312
      • Leipzig, Germany, 04107
      • München, Germany, 80331
      • Nürnberg, Germany, 90402
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Lombardia
      • Castellanza, Lombardia, Italy, 21053
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20122
  • Mexico
      • Aguascalientes, Mexico, 20127
      • Guadalajara, Mexico, 44610
      • Monterrey, Mexico, 64460
      • Saltillo, Mexico, 25000
  • Poland
      • Gdansk, Poland, 80-282
      • Leszno, Poland, 64-100
      • Torun, Poland, 87-100
      • Warszawa, Poland, 02-097
  • Romania
      • Bucharest, Romania, 041914
      • Bucharest, Romania, Sect 4
  • Slovakia
      • Bratislava, Slovakia, 825 56
      • Michalovce, Slovakia, 071 01
  • Spain
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28034
      • Malaga, Spain, 29010
    • Barcelona
      • BArcelon, Barcelona, Spain, 08034
    • Girona
      • Salt, Girona, Spain, 17090
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
  • United Kingdom
      • Blackpool, United Kingdom, FY20JH
      • Bradford, United Kingdom, BD30DQ
      • Glasgow, United Kingdom, G20 0XA
      • Southampton, United Kingdom, SO30 3JB
  • United States
    • California
      • Orange, California, United States, 92868
      • Torrance, California, United States, 90502
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
    • Florida
      • Delray Beach, Florida, United States, 33445
      • Ft Myers, Florida, United States, 33912
      • Maitland, Florida, United States, 32751
      • Tampa, Florida, United States, 33613
      • Tampa, Florida, United States, 33613-4706
    • Kentucky
      • Paducah, Kentucky, United States, 42003
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
    • New York
      • White Plains, New York, United States, 10605
    • Oregon
      • Portland, Oregon, United States, 97210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, >/=50 years of age;
  • probable Alzheimer's disease;
  • MMSE score at screening of 13-22;
  • under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline;
  • not requiring nursing home care, but looked after by a caregiver/carer.

Exclusion Criteria:

  • dementia due to condition other than Alzheimer's disease;
  • other significant neurological disorder;
  • untreated/non-stabilized major depressive disorder;
  • bipolar disorder, schizophrenia, or any other serious psychiatric condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
po daily for 24 weeks
Experimental: RO5313534 15mg
Drug: RO5313534
1mg po daily for 24 weeks
Drug: RO5313534
5mg po daily for 24 weeks
Drug: RO5313534
15mg po daily for 24 weeks
Experimental: RO5313534 1mg
Drug: RO5313534
1mg po daily for 24 weeks
Drug: RO5313534
5mg po daily for 24 weeks
Drug: RO5313534
15mg po daily for 24 weeks
Experimental: RO5313534 5mg
Drug: RO5313534
1mg po daily for 24 weeks
Drug: RO5313534
5mg po daily for 24 weeks
Drug: RO5313534
15mg po daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
Time Frame: At intervals up to week 24, then at week 28
At intervals up to week 24, then at week 28
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
Time Frame: At intervals to week 24, then at week 28
At intervals to week 24, then at week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

April 17, 2009

First Submitted That Met QC Criteria

April 17, 2009

First Posted (Estimate)

April 20, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WN22018
  • 2008-004012-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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