Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

June 10, 2019

Primary Completion Date

April 19, 2022

Study Completion Date

April 19, 2022

Conditions
Alzheimer Disease
Interventions
DRUG

Crenezumab

Crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.

DRUG

Placebo

Placebo matched to crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.

OTHER

[^18F]GTP1

IV \[\^18F\]GTP1 will be administered up to three times. The first primary \[\^18F\]GTP1 tau PET scan will occur during any visit in the main protocol NCT01998841 (GN28352) from Week 130 to Week 224 and the second \[\^18F\]GTP1 tau PET scan from Week 248 to Week 260. The third and optional \[\^18F\]GTP1 tau PET scan will supplement the two primary scans.

Trial Locations (1)

Unknown

Grupo Neurociencias de Antioquia, Medellín

All Listed Sponsors
collaborator

Banner Alzheimer's Institute

OTHER

collaborator

National Institute on Aging (NIA)

NIH

lead

Hoffmann-La Roche

INDUSTRY

NCT03977584 - Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease | Biotech Hunter | Biotech Hunter