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

Roche

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Crenezumab; Drug: Placebo; Other: [^18F]GTP1

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03977584

BN40199

Details and patient eligibility

About

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).

Enrollment: 114 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups, including a placebo group

[^18F]GTP1 in Mutation Carriers: Crenezumab

Experimental group

Description:

Mutation-carrying participants receiving crenezumab in the main study NCT01998841 (GN28352) will receive up to three IV injections of \[\^18F\]GTP1 and will undergo a tau PET scan after each IV injection of \[\^18F\]GTP1.

Treatment:

Drug: Crenezumab

Other: [^18F]GTP1

[^18F]GTP1 in Mutation Carriers: Placebo

Placebo Comparator group

Description:

Mutation-carrying participants receiving placebo in the main study NCT01998841 (GN28352) will receive up to three IV injections of \[\^18F\]GTP1 and will undergo a tau PET scan after each IV injection of \[\^18F\]GTP1.

Treatment:

Drug: Placebo

Other: [^18F]GTP1

[^18F]GTP1 in Non-carriers of Mutation: Placebo

Placebo Comparator group

Description:

Non-carriers of the mutation receiving placebo in the main study NCT01998841 (GN28352) will receive up to three IV injections of \[\^18F\]GTP1 and will undergo a tau PET scan after each IV injection of \[\^18F\]GTP1.

Treatment:

Drug: Placebo

Other: [^18F]GTP1