Genetic Studies of Early-onset Dementia

Recruiting

• Conditions: Dementia, Early Onset
• Interventions: Genetic: Blood draw; Other: Neurocognitive testing; Other: Medical questionnaire

• Registration Number: NCT04906863
• Lead Sponsor: Columbia University

Brief Summary

The aim of this study is to identify genetic factors that contribute to risk and progression of early-onset dementia (loss of memory function before the age of 70 years) across all ethnic groups, including Alzheimer's Disease, mild cognitive impairment and other dementias.

Detailed Description

The study population includes individuals affected by Alzheimer's Disease, mild cognitive impairment, other dementias, cognitively healthy individuals without memory problems, or their family members.

Ascertainment is across both males and females, and all race and ethnic groups.

Study Timeline

• Study Start: 2016-09-14
• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2028-04-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

-Individuals with competing diagnosis such as Huntington's disease, traumatic brain injury, drug or alcohol abuse, or schizophrenia, etc., unless family members of a dementia affected individual

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild Cognitive Impairment	Blood draw	Individuals with mild cognitive impairment that began before age 70
Dementia/Alzheimer's Disease	Medical questionnaire	Individuals with Alzheimer's Disease or other dementia that began before age 70
Mild Cognitive Impairment	Medical questionnaire	Individuals with mild cognitive impairment that began before age 70
Dementia/Alzheimer's Disease	Blood draw	Individuals with Alzheimer's Disease or other dementia that began before age 70
Cognitively Healthy	Blood draw	Cognitively healthy individuals over the age of 30 years
Mild Cognitive Impairment	Neurocognitive testing	Individuals with mild cognitive impairment that began before age 70
Dementia/Alzheimer's Disease	Neurocognitive testing	Individuals with Alzheimer's Disease or other dementia that began before age 70
Cognitively Healthy	Neurocognitive testing	Cognitively healthy individuals over the age of 30 years
Cognitively Healthy	Medical questionnaire	Cognitively healthy individuals over the age of 30 years

Primary Outcome Measures

Name	Time	Method
Genetic risk variants associated with early-onset dementia	2 years	Genetic factors will be measured through genome-wide genotyping arrays and/or whole-genome sequencing, and then correlated with Alzheimer disease and related phenotypes, such as cognitive impairment, functional impairment, and relevant biomarkers.
Changes in blood biomarkers in early-onset dementia	2 years	Blood biomarkers including plasma amyloid beta and tau protein will be assessed in blood and correlated with onset and progression of memory loss and functional impairment

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States