Clinical trial NCT00884507: A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 389
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
timeFrame: Week 24
Secondary outcomes:
measure: CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
timeFrame: At intervals up to week 24, then at week 28
measure: AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
timeFrame: At intervals to week 24, then at week 28
Other outcomes:
Locations:
city: Orange
country: United States
state: California
city: Torrance
country: United States
state: California
city: Norwalk
country: United States
state: Connecticut
city: Delray Beach
country: United States
state: Florida
city: Ft Myers
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Paducah
country: United States
state: Kentucky
city: Kalamazoo
country: United States
state: Michigan
city: Creve Coeur
country: United States
state: Missouri
city: Eatontown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: White Plains
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Caba
country: Argentina
city: Hornsby
country: Australia
state: New South Wales
city: Chermside
country: Australia
state: Queensland
city: Woodville
country: Australia
state: South Australia
city: Medicine Hat
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Verdun
country: Canada
state: Quebec
city: Regina
country: Canada
state: Saskatchewan
city: Montpellier
country: France
city: Nice
country: France
city: St Herblain
country: France
city: Toulouse
country: France
city: Günzburg
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Nürnberg
country: Germany
city: Napoli
country: Italy
state: Campania
city: Castellanza
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Aguascalientes
country: Mexico
city: Guadalajara
country: Mexico
city: Monterrey
country: Mexico
city: Saltillo
country: Mexico
city: Gdansk
country: Poland
city: Leszno
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bratislava
country: Slovakia
city: Michalovce
country: Slovakia
city: BArcelon
country: Spain
state: Barcelona
city: Salt
country: Spain
state: Girona
city: Barakaldo
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Blackpool
country: United Kingdom
city: Bradford
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: