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's Disease	Drug: AChEI - Either donepezil or galantamine or rivastigmine with or without memantine Drug: RO4602522 1 mg Drug: RO4602522 5 mg Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

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 ]


Enrollment:	531
Study Start Date:	October 2012
Study Completion Date:	June 2015
Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Matching oral dose tablet (0.5 mg or 2.5 mg) taken from each of 2 bottles daily for 12 months, in addition to background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine	Drug: AChEI - Either donepezil or galantamine or rivastigmine with or without memantine Either donepezil or galantamine or rivastigmine (AChEI) alone or in combination with memantine is administered to patients as a background therapy; which one is used depends on the background therapy that each individual patient was following before enrollment. Drug: placebo Matching dose tablet (0.5 mg or 2.5 mg) taken from each of 2 bottles daily for 12 months
Experimental: RO4602522 1 mg 2 x 0.5 mg tablets taken daily orally for 12 months, in addition to background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine	Drug: AChEI - Either donepezil or galantamine or rivastigmine with or without memantine Either donepezil or galantamine or rivastigmine (AChEI) alone or in combination with memantine is administered to patients as a background therapy; which one is used depends on the background therapy that each individual patient was following before enrollment. Drug: RO4602522 1 mg 2 x 0.5 mg tablets taken daily orally for 12 months
Experimental: RO4602522 5 mg 2 x 2.5 mg tablets taken daily orally for 12 months, in addition to background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine	Drug: AChEI - Either donepezil or galantamine or rivastigmine with or without memantine Either donepezil or galantamine or rivastigmine (AChEI) alone or in combination with memantine is administered to patients as a background therapy; which one is used depends on the background therapy that each individual patient was following before enrollment. Drug: RO4602522 5 mg 2 x 2.5 mg tablets taken daily orally for 12 months

Eligibility


Ages Eligible for Study:	50 Years to 90 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Show 142 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


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:	August 4, 2016
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Alzheimer Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Dementia Tauopathies Memantine Galantamine Rivastigmine Donepezil Antiparkinson Agents Anti-Dyskinesia Agents	Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Cholinesterase Inhibitors Enzyme Inhibitors Cholinergic Agents Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Nootropic Agents Neuroprotective Agents Protective Agents

ClinicalTrials.gov processed this record on September 30, 2016