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Report for Clinical Trial NCT03977584

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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).

NCT03977584 Alzheimer Disease
MeSH:Alzheimer Disease
HPO:Alzheimer disease

3 Interventions

Name: Crenezumab

Description: Crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.
Type: Drug
Group Labels: 3

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

Name: Placebo

Description: Placebo matched to crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.
Type: Drug
Group Labels: 6

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

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.
Type: Other
Group Labels: 9

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


Primary Outcomes

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

Time: Approximately from main study NCT01998841 (GN28352) Week 130 up to Week 260

Purpose: Other

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 E280A

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. --- E280A ---

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 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). --- E280A ---

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 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). --- E280A --- --- E280A ---



HPO Nodes


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