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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2022-04-19

Brief Summary

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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).

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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[^18F]GTP1 in Mutation Carriers: Crenezumab

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.

Group Type EXPERIMENTAL

Crenezumab

Intervention Type DRUG

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

[^18F]GTP1

Intervention Type OTHER

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.

[^18F]GTP1 in Mutation Carriers: Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

[^18F]GTP1

Intervention Type OTHER

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.

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

[^18F]GTP1

Intervention Type OTHER

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.

Interventions

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Crenezumab

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

[^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.

Intervention Type OTHER

Other Intervention Names

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MABT5102A

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No