Health conditions
(Data source: WHO)
MILD ALZHEIMER?S DISEASE
MedDRA version: 16.1Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Interventions (Data source: WHO)
Product Name: Gantenerumab
Product Code: Ro 490-9832/F12
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: gantenerumab
CAS Number: n/a
Current Sponsor code: RO4909832
Other descriptive name: human anti-A? antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 105-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: Gantenerumab
Product Code: Ro 490-9832/F14
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: gantenerumab
CAS Number: n/a
Current Sponsor code: RO4909832
Other descriptive name: human anti-A? antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 225-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender:
Female: yes
Male: yes
Inclusion criteria:
- Adult patients, 50 to 90 years of age, inclusive
- Clinical diagnosis of probable mild Alzheimer disease based on NINCDS/ADRDA criteria
- 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, doses must have been stable for at least 5 months prior to randomization
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 900
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 abuse or dependence (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
-
Further information on trial
Date trial registered
Dec 27, 2013
Incorporation of the first participant
Feb 24, 2014
Recruitment status
Not Recruiting
Academic title
(Data source: WHO)
A Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety study of Gantenerumab in patients with Mild Alzheimer?s disease
Type of trial
(Data source: WHO)
Interventional clinical trial of medicinal product
Design of the trial
(Data source: WHO)
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
Phase
(Data source: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primary end point
(Data source: WHO)
Main Objective: to evaluate the efficacy of gantenerumab compared with placebo administered to patients by SC injection over 100 weeks as measured by the following co-primary endpoints (final outcome assessment 4 weeks after the final dose):
? Cognition measured by the Alzheimer?s Disease Activity Scale?Cognitive (ADAS-Cog) (13-item)
? Function assessed by the Alzheimer?s Disease Cooperative Study?Activities of Daily Living (ADCS-ADL);Secondary Objective: 1. to evaluate the benefits of gantenerumab versus placebo administered to patients by SC injection over 100 weeks on slowing clinical decline and disease progression by assessing the following:
? Time to clinically evident decline
? Disease pathology biomarkers
2. Additional secondary endpoints
? Global: Effect on severity of dementia and global measures of cognition and function
? Cognition: Effect on cognition
? Behavioar: Effect on behavioral and neuropsychological symptoms of AD
? Other AD symptoms and effects: Effect of gantenerumab on health-related QoL, patient-individualized goal achievement (sites in English- and French-speaking countries only), on caregiver emotional well-being, on the amount of assistance patients with dementia require in performing daily activities;Primary end point(s): Mean change in Alzheimer's Disease Activity Scale-Cognitive subscale 13 (ADAS-Cog13) scores
Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores;Timepoint(s) of evaluation of this end point: - from baseline to Week 104
Secundary end point
(Data source: WHO)
Secondary end point(s): - Change in biomarkers (t-tau, p-tau, Abeta 1-42 levels) in cerebral spinal fluid
- Change in MRI volumetry, assessed on structural MRI
- Change in Clinical Dementia Rating (CDR-SB/CDR-GS)
- Change in neuropsychiatric behaviour: Neuropsychiatric Inventory (NPI) total and domain scores
- Change in cognition: MMSE total score
- Safety: Incidence of adverse events, serious adverse events and treatment discontinuations;Timepoint(s) of evaluation of this end point: - from baseline to Week 104
- from baseline to Week 104
- from baseline to Week 104
- from baseline to Week 104
- from baseline to Week 104
- 152 weeks
Contact information
(Data source: WHO)
F.Hoffmann-La Roche Ltd.
Trial results
(Data source: WHO)
Results summary
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients
Information on the availability of individual participant data
no information available yet
Trial sites
Countries
(Data source: WHO)
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hungary, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Republic of, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contact for further information on the trial
Contact for general information
(Data source: WHO)
Trial Information Support Line-TISL
Grenzacherstrasse 124
F.Hoffmann-La Roche Ltd.
global.rochegenentechtrials@roche.com
Contact for scientific information
(Data source: WHO)
Trial Information Support Line-TISL
Grenzacherstrasse 124
F.Hoffmann-La Roche Ltd.
global.rochegenentechtrials@roche.com
Further trial identification numbers
Secondary ID (Data source: WHO)
WN28745
2013-003390-95-GB
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