CompletedPhase 2Results posted

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

Tau PET Longitudinal Substudy Associated With: A Double-Blind, Placebo-Controlled Parallel-Group Study in Preclinical PSEN1 E280A Mutation Carriers Randomized to Crenezumab or Placebo, and in Non-randomized, Placebo-treated Non-carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Crenezumab in the Treatment of Autosomal-Dominant Alzheimer's Disease

Lead sponsor

Hoffmann-La Roche

Asset

Crenezumab

Listed sites

Recruiting sites

Enrollment

114

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 30-60

Primary endpoint

•Annualized Rate of Change in Tau Burden

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDBN40199

NCT IDNCT03977584

Timeline

Milestones

Study first posted2019-06-06actual

Study start2019-06-10actual

Primary completion2022-04-19actual

Study completion2022-04-19actual

Last update posted2024-03-15actual

Results first posted2024-03-15actual

Assets

Drug assets

Crenezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age30 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Memory

2 endpoints

Primary/protocol endpoint

Annualized Rate of Change in Tau Burden

Time frame:Baseline up to Week 149

change from baseline, improvement

Primary/registry result

Annualized Rate of Change in Tau Burden

Time frame:Baseline up to Week 149

change from baseline, improvement

Posted result

Group	Value (mean), SUVR per year	Standard error
Crenezumab - Mutation Carriersn=44 Participants	0.0124	0.00752
Placebo - Mutation Carriersn=39 Participants	0.0254	0.00768

Difference in Annualized Rate of Change-0.013095% CI-0.0327 - 0.0068p0.1953RCRM

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.