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

Phase 3

Withdrawn

• Conditions: dementia; eurologisch; ziekte van Alzheimer; Alzheimer's disease

• Registration Number: NL-OMON50277
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

* Ability to provide written informed consent and has signed the Informed
Consent Form
* Age 60-80 years old (inclusive) at time of signing the Informed Consent Form
* Willingness and ability to comply with the study protocol, and complete all
aspects of the study (including cognitive and functional assessments, physical
and neurological examinations, MRI, CSF collection, genotyping, and PET imaging)
* Cognitively unimpaired with a screening CDR-GS of 0, MoCA score 26 or > 26
and RBANS DMI 85 -115
* Evidence of cerebral amyloid accumulation, as confirmed by a combined measure
of quantitative and qualitative amyloid PET or CSF pTau/A(-42 ratio
* Availability of a person (study partner* throughout the study) in the
investigator's judgment
- Participants who are fluent in the language of the tests used at the study
site
- Participants who have adequate visual and auditory acuity, sufficient to
perform
neuropsychological testing (eye glasses and hearing aids are permitted)
- Participants who have agreed not to donate blood or blood products for
transfusion
for the duration of the study and for 1 year after the final dose of study drug
- Participants who have agreed not to participate in other interventional
research
studies for the duration of this trial
- For women of childbearing potential: agreement to remain abstinent (refrain
from
heterosexual intercourse) or use contraceptive methods that result in a failure
rate
of < 1% per year during the treatment period and for at least 17 weeks after
the final
dose of study treatment

Exclusion Criteria

- Exclusions Related to CNS Disorders:
- Any evidence of an underlying neurological or neurodegenerative condition
that may
lead to cognitive impairment other than AD, including, but not limited to,
frontotemporal dementia, dementia with Lewy bodies, vascular dementia,
Parkinson*s disease, corticobasal syndrome, Creutzfeldt-Jakob disease,
progressive
supranuclear palsy, frontotemporal lobar degeneration, Huntington disease,
normal
pressure hydrocephalus, seizure disorder, delirium, hypoxia, or encephalopathy
related to prior COVID-19 infection
- Clinical diagnosis of MCI, prodromal AD, or any form of dementia
- History or presence of intracranial or intracerebral vascular malformations,
aneurysm, subarachnoid hemorrhage, or intracerebral macrohemorrhage
- History or presence of posterior reversible encephalopathy syndrome
- History of ischemic stroke with clinical symptoms or an acute event that is
consistent
with a transient ischemic attack within 12 months of screening
- History of severe, clinically significant (i.e., resulting in persistent
neurologic deficit
or structural brain damage) CNS trauma (e.g., cerebral contusion)
- History or presence of intracranial mass lesion (e.g., glioma, meningioma)
that could
potentially impair cognition or lead to progressive neurological deficits
- Infections that may affect brain function or a history of infections that
resulted in
neurologic sequelae (e.g., HIV, syphilis, neuroborreliosis, and viral or
bacterial
meningitis and encephalitis)
- History of major depression, schizophrenia, schizoaffective disorder, or
bipolar
disorder
History or presence of major depression is acceptable if the participant is
considered to be in remission or depression is controlled by treatment and the
participant has had no episode of major depression within 12 months of
screening.
- At risk for suicide
- History of alcohol and/or substance abuse or dependence (according to the
criteria
specified in the Diagnostic and Statistical Manual of Mental Disorders, Version
5)
within 2 years of screening
- Exclusions Related to Imaging Related Criteria
- Exclusions Related to Cardiovascular Disorders
- Exclusions Related to Hepatic and Renal Disorders
- Exclusions Related to Infections and Immune Disorders
- Exclusions Related to Metabolic and Endocrine Disorders
- Exclusions Related to Medications
- Other Exclusions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: To evaluate the efficacy of gantenerumab compared with<br /><br>control on cognition<br /><br><br /><br>Primary endpoint:<br /><br>Change from baseline to Year 4 in the Preclinical Alzheimer's Cognitive<br /><br>Composite-5 (PACC-5) score</p><br>