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

Sponsors

Lead Sponsor: Hoffmann-La Roche

Collaborator: Banner Alzheimer's Institute
National Institute on Aging (NIA)

Source Hoffmann-La Roche
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).

Overall Status Recruiting
Start Date 2019-06-10
Completion Date 2022-03-31
Primary Completion Date 2022-03-31
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change Over Time in tau Distribution Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by [^18F]GTP1 tau PET Scan Baseline up to Week 416
Enrollment 150
Condition
Intervention

Intervention Type: Drug

Intervention Name: Crenezumab

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

Arm Group Label: [^18F]GTP1 in Mutation Carriers: Crenezumab

Other Name: MABT5102A

Intervention Type: Drug

Intervention Name: Placebo

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

Intervention Type: Other

Intervention Name: [^18F]GTP1

Description: 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.

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

Minimum Age:

30 Years

Maximum Age:

60 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Clinical Trials Study Director Hoffmann-La Roche
Overall Contact

Last Name: Reference Study ID Number: BN40199 www.roche.com/about_roche/roche_worldwide.htm

Phone: 888-662-6728 (U.S. Only)

Email: [email protected]

Location
Facility: Status: Grupo Neurociencias de Antioquia
Location Countries

Colombia

Verification Date

2021-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

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

Type: Experimental

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.

Label: [^18F]GTP1 in Mutation Carriers: Placebo

Type: Placebo Comparator

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.

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

Type: Placebo Comparator

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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News