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

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Alzheimer disease type 3
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Brief Title

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

Official Title

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

Brief 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).

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Change Over Time in tau Distribution Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by [^18F]GTP1 tau PET Scan

Condition

Alzheimer Disease

Intervention

Crenezumab

Study Arms / Comparison Groups

 [^18F]GTP1 in Mutation Carriers: Crenezumab
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

150

Start Date

June 10, 2019

Completion Date

April 19, 2022

Primary Completion Date

April 19, 2022

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.

Gender

All

Ages

30 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Clinical Trials, ,

Location Countries

Colombia

Location Countries

Colombia

Administrative Informations

NCT ID

NCT03977584

Organization ID

BN40199

Responsible Party

Sponsor

Study Sponsor

Hoffmann-La Roche

Collaborators

 Banner Alzheimer's Institute

Study Sponsor

Clinical Trials, Study Director, Hoffmann-La Roche

Verification Date

May 2022