Phase 2
N=114
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
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03977584 ↗Enrolled (actual)
114
Serious AEs
7.9%
Results posted
Mar 2024
Primary outcome: Primary: Annualized Rate of Change in Tau Burden — 0.0124; 0.0254 SUVR per year — p=0.1953
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Crenezumab (Drug); Placebo (Drug); [^18F]GTP1 (Other)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Rate of Change in Tau Burden |
0.0124; 0.0254 | 0.1953 |
Summary
This substudy will evaluate the effect of crenezumab on the longitudinal tau burden in a subgroup of preclinical Presenilin1 (PSEN1) E280A mutation carriers and non-carriers, who were enrolled in study NCT01998841 (GN28352). Participants will receive up to three intravenous (IV) injections of [^18F] Genentech Tau Probe 1 (GTP1) and will undergo a tau positron emission tomography (PET) scan after each IV injection of [18^F]GTP1. The purpose of this substudy is to increase the understanding of disease progression in the preclinical stage of familial Alzheimer's Disease (AD).
Eligibility Criteria
Inclusion Criteria
- Enrolled in main Study NCT01998841 (GN28352).
Exclusion Criteria
- Contraindication to PET scan procedures, possibly including, but not limited to current, past, or planned participation in studies involving radioactive agents, including the main Study NCT01998841 (GN28352) and this Tau PET substudy, such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.
Data sourced from ClinicalTrials.gov (NCT03977584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.