A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-033-17

Enrollment

Registered

2018-01-24

Start date

2018-04-18

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

1 vial gantenerumab 300 mg/2ml subcutaneous inyection at a dose of 135 mg SC Q4W for 3 months, 270 mg SC Q4W for 3 months, and 540 mg SC Q4W for 3 months, prior to reaching 1080 mg (see Figure

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ability to provide written consent signed by the patient (co-signed by the patient’s legally authorized representative, if required by the local regulations, guidelines, and independent Ethics Committee 2. Age 50−90 years old at screening, inclusive 3. Evidence of AD pathological process, as confirmed by CSF tau/Aβ42 or on amyloid PETscan by qualitative read by the core/central PET laboratory. 4.Probable AD dementia (consistent with NIA/AA core clinical criteria for probable AD dementia) or prodromal AD (consistent with the NIA/AAdiagnostic criteria and guidelines for mild cognitive decline due to AD)

Exclusion criteria

Exclusion criteria: 1. Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson’s disease, corticobasal degeneration, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal degeneration, Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium or hypoxia

Countries

Australia, Brazil, Bulgaria, Canada, Colombia, Czech Republic, El Salvador, France, Germany, Hungary, Italy, Japan, Lithuania, Malasya, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Taiwan, Ukraine, United States

Contacts

Public ContactPilar Leslie Kikushima

ROCHE FARMA (PERU) S.A.

leslie.kikushima@roche.com6302994

Outcome results