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NCT Number: NCT00884507

A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

po daily for 24 weeks

RO5313534

Drug

1mg po daily for 24 weeks

Primary outcomes

  1. Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score

    Time frame: Week 24

Secondary outcomes

  1. 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

  2. AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.

    Time frame: At intervals to week 24, then at week 28

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2009
Registry last updated
Nov 2, 2016

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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