Prognostic and Natural History Study

Phase 1

Active, not recruiting

• Conditions: Alzheimer's Disease; Therapeutic area: Health Care [N] - Population Characteristics [N01]

• Registration Number: EUCTR2018-002277-22-ES
• Lead Sponsor: Stichting VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-23
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Baseline Eligibility Criteria
1. Participants who are currently active in the EPAD LCS and older than 50 years of age will be eligible if they provide separate written informed consent to participate in the AMYPAD PNHS
2. Participants with a suitable baseline biomarker, cognitive and risk factor profile, as determined by the Selection and Feasibility Committee, based on an adaptive selection algorithm that aims to provide optimal representation of the probability spectrum for AD risk; OR participants that have been randomly selected to maintain the mandated
nondisclosure EPAD LCS.
3. Participants who are assessed by the recruiting investigator to be physically fit to undergo PET scanning and able to tolerate the PET scanning procedure for at least the duration of a static scan (20 minutes).

Follow-up Eligibility Criteria
1. Participants who underwent dynamic PET scanning at baseline:
a. Participants who are willing and available to undergo a follow-up
scan. All participants with a dynamic scan at baseline will be invited for
follow-up scans.
2. Participants who underwent static PET scanning at baseline:
a. Participants who are willing and available to undergo a follow-up
scan, and
b. Are selected based on the Selection and Feasibility Committee's
algorithm for follow-up, which in addition to the previous algorithm also
considers baseline composite SUVR values.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1200

Exclusion Criteria

1. Participants who are not currently active in the EPAD LCS.
2. Participants in whom PET scanning or magnetic resonance imaging (MRI) are contraindicated.
3. Participants who are not able to complete the study procedures as judged by the investigator.
4. Participants who have known hypersensitivities to the active ingredients of [18F]flutemetamol and [18F]florbetaben, or the excipients for both products (listed in section 6.1 of the respective Summary of Product Characteristics [SPC]).
5. Women who are pregnant, planning to become pregnant, or lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified