A Study of Gantenerumab in Participants With Mild Alzheimer Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 20 February 2023
• Main ID: NCT02051608
• Date of registration: 30/01/2014
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Gantenerumab in Participants 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: March 27, 2014
• Target sample size: 389
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02051608
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

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: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of probable mild Alzheimer disease (AD) based on National Institute
of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related
Disorders Association (NINCDS/ADRDA) criteria or major NCD based whether or not
receiving AD approved medication

- Cerebral spinal fluid (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 participant, and is able to provide accurate
information regarding the participant'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

PART 2 - All participants who have been randomized and are actively participating in the
study are eligible for Part 2

Exclusion Criteria:

- Dementia or neurocognitive disorder (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

Part 2 Participants who have been discontinued from the study



Age minimum: 50 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Drug: Gantenerumab

Drug: Placebo

Primary Outcome(s)

Part 2: Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) [Time Frame: First dose up to last dose (Baseline up to until maximum 5 years)]

Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time Frame: First dose up to 4 weeks after the last dose of study drug (up to 249 weeks)]

Part 2: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment [Time Frame: First dose up to 4 weeks after the last dose in OLE (Up to approximately 249 weeks)]

Secondary Outcome(s)

Part 1: Gantenerumab Plasma Concentration at Multiple Timepoints [Time Frame: Pre-dose: Weeks 4, 8, 12, 24, 48, 72 and Post dose: Day 4]

Part 1: Percentage of Participants With AEs, SAEs [Time Frame: First dose up to last dose (Up to approximately 152 weeks)]

Part 2: Gantenerumab Plasma Concentration at Multiple Timepoints [Time Frame: Pre-dose: Weeks 104, 116, 156, 208; Post-dose: Weeks 53, 101]

Part 2: Change From Baseline in Brain Amyloid Load at Week 156 in a Subset of Participants [Time Frame: Baseline, Week 156]

Part 2: Percent Change From Baseline in Whole Brain Volume at Week 104 [Time Frame: Baseline (Part 1 screening), Week 104]

Part 1: Percentage of Participants With Adverse Events Leading to Discontinuation of Treatment [Time Frame: First dose up to last dose (Up to approximately 152 weeks)]

Part 2: Percent Change From Baseline in Cortical Thickness at Week 104 [Time Frame: Baseline (Part 1 screening), Week 104]

Part 1: Percentage of Participants With Treatment Emergent ADAs [Time Frame: First dose up to last dose (Up to approximately 152 weeks)]

Part 2: Ventricular Volume as Measured by MRI at Week 104 [Time Frame: Part 2: Week 104]

Part 2: Percent Change From Baseline in Hippocampal Volume at Week 104 [Time Frame: Baseline (Part 1 screening), Week 104]

Secondary ID(s)

2013-003390-95

WN28745

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/06/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02051608