MAyflOwer RoAD Study: A Study of RO4602522 in Patients With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy - Full Text View

Purpose

This phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in patients with moderate severity Alzheimer disease. Patients who are taking background therapy of acetylcholinesterase inhibitors 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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: RO4602522 Drug: RO4601522 Drug: placebo Drug: donepezil Drug: rivastigmine Drug: galantamine Drug: memantine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RO4602522 ADDED TO BACKGROUND ALZHEIMER'S DISEASE THERAPY IN PATIENTS WITH MODERATE SEVERITY ALZHEIMER'S DISEASE

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Galantamine Galantamine hydrobromide Memantine Memantine hydrochloride Donepezil hydrochloride Donepezil Rivastigmine Rivastigmine tartrate

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change in Alzheimer's Disease Assessment Scale - Cognitive Behaviour Subscale (ADAS-Cog-11) score [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Alzheimer's disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale score [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
Effect on behavioural symptoms: Change in Behavioural Pathology in Alzheimer's Disease Frequency-Weighted Severity Scale (BEHAVE-AD-FW)/Apathy Evaluation Scale (AES) score [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
Effect on global measures: Alzheimer's Disease Cooperative Study Clinician Global Impression of Change (ADCS-CGIC) scale/Global Deterioration Scale (GDS) at 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	495
Study Start Date:	November 2012
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: RO4602522 Dose A	Drug: RO4602522 Dose A, 12 months Drug: donepezil stable dose background medication Drug: rivastigmine stable dose background medication Drug: galantamine stable dose background medication Drug: memantine stable dose background medication in combination with AChEIs
Experimental: RO4602522 Dose B	Drug: RO4601522 Dose B, 12 months Drug: donepezil stable dose background medication Drug: rivastigmine stable dose background medication Drug: galantamine stable dose background medication Drug: memantine stable dose background medication in combination with AChEIs
Placebo Comparator: Placebo	Drug: placebo 12 months Drug: donepezil stable dose background medication Drug: rivastigmine stable dose background medication Drug: galantamine stable dose background medication Drug: memantine stable dose background medication in combination with AChEIs

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients, 50-90 years of age inclusive at time of screening
Probable Alzheimer disease, based on the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS)/Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR criteria
MMSE score at screening between 13 and 20, inclusive
Body mass index (BMI) between 18 and 36 kg/m2 (inclusive) at screening
Modified Hachinski Ischemia Score of </= 4
Patients with Cornell Scale for Depression in Dementia (CSDD) scores </= 13 at screening
Receiving treatment with donepezil or rivastigmine, galantamine or any of these AChEIs in combination with memantine for at least 4 months before screening, with their dose and formulation stabilized at least 3 months before screening. All formulation and dosages are allowed except donezepil 23 mg (alone or in combination)
Females of childbearing potential must have a negative pregnancy test and must agree to use effective contraception
Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane)
Have a reliable caregiver or some other identified responsible person who has frequent contact with the patient

Exclusion Criteria:

Any neurological or psychiatric condition that may currently or during the course of the study impair cognition or functioning that is not associated with Alzheimer's disease
Background of mental retardation
Uncontrolled behavioral symptoms incompatible with compliance or evaluability
Alcohol and/or substance abuse or dependence (DSM-IV-TR) in the past 2 years, except nicotine use which is allowed. However, smokers treated with nicotine replacement therapy or bupropion are excluded
Unstable or poorly controlled hypertension as assessed by the investigator
Unstable or clinically significant cardiovascular disease that could be expected to progress, recur, or change during study period to such an extent that it could bias the assessment of the clinical or mental status of the patient
Inadequate hepatic, renal or thyroid function
Positive for hepatitis B, hepatitis C or HIV infection
Poorly controlled diabetes
Requiring nursing home care. Patients living in assisted living facilities are allowed if a reliable caregiver is available (see inclusion criteria)
Current treatment for AD other than those listed in inclusion criteria
Participation at any time in an active AD vaccine study
Participation in a passive AD immunization study less than 1 year before screening, with exceptions as per protocol
Psychotropic medication as defined by protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677754

Contacts

Contact: Reference Study ID Number: BP28248 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

global.rochegenentechtrials@roche.com

Show 130 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01677754 History of Changes
Other Study ID Numbers:	BP28248
Study First Received:	August 30, 2012
Last Updated:	June 18, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Galantamine
Donepezil
Rivastigmine
Memantine
Parasympathomimetics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents

ClinicalTrials.gov processed this record on June 18, 2013