A Study of Gantenerumab in Patients With Mild Alzheimer Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02051608
First received: January 30, 2014
Last updated: August 1, 2016
Last verified: August 2016
  Purpose

This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in patients with mild Alzheimer disease. Patients will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening.

A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible patients who provide separate informed consent will undergo up to four PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time. The substudy's target sample size is 100 patients in each arm of the main study.


Condition Intervention Phase
Alzheimer's Disease
Drug: florbetapir
Drug: gantenerumab
Drug: placebo
Phase 3

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 III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, EFFICACY AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH MILD ALZHEIMER'S DISEASE

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • PET imaging substudy: Change in brain amyloid load over time using florbetapir [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Mean change in Alzheimer's Disease Activity Scale-Cognitive subscale 13 (ADAS-Cog13) scores [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in biomarkers (t-tau, p-tau, Abeta 1-42 levels) in cerebral spinal fluid [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Change in MRI volumetry, assessed on structural MRI [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Change in Clinical Dementia Rating (CDR-SB/CDR-GS) [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Change in neuropsychiatric behavior: Neuropsychiatric Inventory (NPI) total and domain scores [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Change in cognition: MMSE total score [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events, serious adverse events and treatment discontinuations [ Time Frame: 152 weeks ] [ Designated as safety issue: No ]
  • Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) [ Time Frame: from baseline to Week 104 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2014
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gantenerumab Drug: gantenerumab
SC q4w up to Week 100
Experimental: PET imaging substudy Drug: florbetapir
intravenous injection of florbetapir [Amyvid™] up to 370 MBq (10 mCi) of florbetapir and imaging for up to 15 minutes per PET scan conducted at screening and on 3 subsequent timepoints per protocol
Other Name: Amyvid
Placebo Comparator: Placebo Drug: placebo
SC q4w

  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 to 90 years of age, inclusive
  • Clinical diagnosis of probable mild Alzheimer disease (AD) based on NINCDS/ADRDA criteria whether or not receiving AD approved medication
  • CSF result consistent with the presence of amyloid pathology
  • Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient contact with the patient, and is able to provide accurate information regarding the patient's cognitive and functional abilities
  • Fluency in the language of the tests used at the study site
  • Willingness and ability to complete all aspects of the study
  • Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted)
  • If currently receiving approved medications for AD, the dosing regimen must have been stable for 3 months prior to screening
  • Agreement not to participate in other research studies for the duration of this trial and its associated substudies

Exclusion Criteria:

  • Dementia or NCD due to a condition other than AD, including, but not limited to, frontotemporal dementia, Parkinson disease, dementia with Lewy bodies, Huntington disease, or vascular dementia
  • History or presence of clinically evident vascular disease potentially affecting the brain that in the opinion of the investigator has the potential to affect cognitive function
  • History or presence of stroke within the past 2 years or documented history of transient ischemic attack within the last 12 months
  • History or presence of systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
  • History of schizophrenia, schizoaffective disorder, or bipolar disorder
  • Alcohol and/or substance use disorder (according to the DSM-5) within the past 2 years (nicotine use is allowed)
  • History or presence of atrial fibrillation
  • Within the last 2 years, unstable or clinically significant cardiovascular disease (e.g., myocardial infarction, angina pectoris, cardiac failure New York Heart Association Class II or higher)
  • Uncontrolled hypertension
  • Chronic kidney disease
  • Impaired hepatic function

PET imaging substudy, in addition to above:

  • Prior participation in other research study or clinical care within the last year such that the total radiation exposure would exceed the local or national annual limits
  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: NCT02051608

Contacts
Contact: Reference Study ID Number: WN28745 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 157 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: NCT02051608     History of Changes
Other Study ID Numbers: WN28745  2013-003390-95 
Study First Received: January 30, 2014
Last Updated: August 1, 2016
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
Neurocognitive Disorders
Mental Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016