A Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer’s Disease

Phase 1

• Conditions: Alzheimer's Disease (AD); MedDRA version: 20.0Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10074616Term: Prodromal Alzheimer's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001384-87-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-31
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age 50-90 years old
• Probable AD dementia or prodromal AD
• Availability of a reliable study partner who accepts to participate in study procedure throughout the study duration
• Evidence of AD pathological process, as confirmed by amyloid PET scan by qualitative read by the core/central PET laboratory
• Prodromal or mild symptomatology, as defined by a screening Mini-Mental State Examination score >= 22 and Clinical Dementia Rating global score of 0.5 or 1.0, as well as a clinical dementia rating memory domain score >= 0.5
• If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 3 months prior to screening and until start of study treatment
• Agreement not to participate in other research studies for the duration of this trial
• For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 16 weeks after the final dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

• Any evidence of a condition other than AD that may affect cognition
• History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
• Uncontrolled hypertension
• Unstable or clinically significant cardiovascular, kidney or liver disease
• History or presence of clinically evident cerebrovascular disease, posterior reversible encephalopathy syndrome, any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent, in the opinion of the investigator, with a transient ischemic attack
• History of severe, clinically significant CNS trauma, history or presence of intracranial mass that could potentially impair cognition
• Any contraindications to brain magnetic resonance imaging
• Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
• History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits
• History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
• At risk for suicide in the opinion of the investigator
• Alcohol and/or substance abuse or dependence within the past 2 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified