Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Early Onset Alzheimer's Disease Caused by a Genetic Mutatio

Phase 1

• Conditions: Dominantly Inherited Alzheimer Disease (DIAD); MedDRA version: 24.1Level: LLTClassification code 10086382Term: Late onset Alzheimer's diseaseSystem Organ Class: 100000004852; MedDRA version: 24.1Level: LLTClassification code 10086384Term: Early onset Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-000307-17-DE
• Lead Sponsor: Washington University in St. Louis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-09
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

Participants must meet ALL inclusion criteria, including EYO:

1. -10 to +10 EYO (secondary prevention population): within -10 to +10 years (inclusive) of the estimated age at symptom onset, CDR 0 to 1, inclusive; known eligible mutation carrier or at 50% risk (affected parent or sibling); or
2. -25 to -11 EYO (primary prevention population): within 11 to 25 years younger than their estimated age at symptom onset, CDR 0, known carrier or mutation in their family pedigree; if the at-risk parent is deemed a non-carrier at any point, participants will be withdrawn from study.
3. Are able and willing to complete the main study-related testing, evaluations, and procedures.
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 725
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Participants will be excluded if they have a major or unstable illness that would prevent trial participation or are unable to complete main study-related testing. Exclusions include MRI contraindications, required anticoagulation and pregnancy. Participants who know they are mutation non-carriers are not eligible.

Study & Design

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