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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 7 June 2021
Main ID:  EUCTR2013-003390-95-PT
Date of registration: 30/12/2013
Prospective Registration: Yes
Primary sponsor: F. Hoffmann-La Roche Ltd
Public title: A Study of Gantenerumab in Patients with Mild Alzheimer Disease
Scientific 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; Part II: open-label extension for participating patients
Date of first enrolment: 07/03/2014
Target sample size: 1000
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003390-95
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Part 2 of the study is open label
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Belgium Brazil Bulgaria Canada Czech Republic Denmark
Finland France Germany Guatemala Hungary Italy Japan Korea, Republic of
Mexico Netherlands Poland Portugal Russian Federation Spain Sweden Switzerland
Turkey United Kingdom United States
Contacts
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 CH-4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F.Hoffmann-La Roche Ltd.
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 CH-4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F.Hoffmann-La Roche Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
- Adult patients, 50 to 90 years of age, inclusive
- Clinical diagnosis of probable mild Alzheimer disease based on NINCDS/ADRDA criteria or major NCD due to AD of mild severity, whether or not receiving AD approved medication
- 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
- Agreement not to participate in other research studies for the duration of this trial and its associated substudies
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
MILD ALZHEIMER’S DISEASE
MedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852
Intervention(s)

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-Aß 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-Aß 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

Product Name: Gantenerumab
Product Code: Ro 490-9832/F10
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GANTENERUMAB
CAS Number: n/a
Current Sponsor code: RO4909832
Other descriptive name: human anti-Aß antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)
Secondary Objective: Part 1: 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
• Change from baseline at Week 104 in CDR-SB
• ADAS-Cog responder
• 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, on caregiver emotional well-being, on the amount of assistance patients with dementia require in performing daily activities
Part 2: To evaluate the effect of higher doses of gantenerumab on imaging biomarkers, CSF biomarkers, and clinical outcome measures, and to explore the PK at the higher doses
Main Objective: Double-blind treatment period (Part 1):
To evaluate the efficacy of gantenerumab administered to patients by SC injection over 100 weeks vs. placebo on measures of cognition (ADASCog) and function (ADCS-ADL). Based on recent findings from the SCarlet RoAD study and from other studies on anti-amyloid antibodies, the study has been amended to allow for higher doses of gantenerumab to be examined in an open-label extension
Open-label extension (Part 2):
To evaluate the safety and tolerability of gantenerumab at higher doses (up to 1200 mg) focusing on physical and neurologic examinations, vital signs, blood safety tests, ECG, and AE monitoring
Primary end point(s): Double-blind treatment period:
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

Open label extension: safety and tolerability of gantenerumab
Timepoint(s) of evaluation of this end point: Double-blind treatment period: 2 years
Open label extension: additional 2 years from start of open label
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: Double-blind treatment period: from baseline to Week 104

Open-label extension: additional 2 years from start of open label
Secondary end point(s): Double-blind treatment period
- 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
- Change in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
- ADAS-Cog responder

Open label extension:
Explore the effect of gantenerumab on clinical outcome measures and biomarker measures
Secondary ID(s)
WN28745
2013-003390-95-GB
Source(s) of Monetary Support
F.Hoffmann-La Roche Ltd.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 07/03/2014
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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