A PHASE III, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGES OF ALZHEIMER’S DISEASE

  • STATUS
    Recruiting
  • End date
    Oct 1, 2028
  • sponsor
    Hoffmann-La Roche
Updated on 24 June 2022
Accepts healthy volunteers

Summary

This study is designed to evaluate the efficacy and safety of Gantenerumab in participants at risk for or at the earliest stages of Alzheimer’s Disease (AD) 

Description

This phase 3, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of Gantenerumab (an anti-beta-amyloid antibody) in amyloid-positive, cognitively unimpaired participants at risk for or at the earliest stages of AD. Eligible participants with proven amyloid positivity on cerebrospinal fluid (CSF) sampling or amyloid positron emission tomography (PET) imaging will be randomized in a ratio of 1:1 to receive either Gantenerumab or placebo via subcutaneous injection with gradual up titration over a duration of 211 weeks. The efficacy of Gantenerumab on change from cognitive baseline to Year 4 will be evaluated using the Preclinical Alzheimer’s Cognitive Composite-5 (PACC-5) score

Contact: Recruitment Team Member
Phone number: 571-418-0142

Details
Condition Cognitively unimpaired participants at risk for or at the earliest stages of Alzheimer’s Disease
Clinical Study IdentifierTX299667
SponsorHoffmann-La Roche
Last Modified on24 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female 60 years to 80 years (inclusive)
Cognitively unimpaired with a Clinical Dementia Rating Global Score (CDR-GS) of 0
No clinical diagnosis of cognitive impairment, Mild Cognitive Impairment (MCI), AD or dementia
Has a reliable study partner available for the study
Adequate visual and auditory ability (eye glasses and hearing aids permitted)

Exclusion Criteria

Any evidence of an underlying neurological or neurodegenerative condition that may lead to cognitive impairment other than AD
History or presence of intracranial or intracerebral vascular malformations, aneurysm, subarachnoid hemorrhage, or intracerebral macrohemorrhage
History of stroke or transient ischaemic attack within 12 months
History of severe, clinically significant central nervous system trauma
History of major depression, schizophrenia, schizoaffective disorder, or bipolar disorder
Typical or atypical antipsychotic medication or neuroleptic medications
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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