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Clinical Trials/NCT04906863
NCT04906863
Recruiting
N/A

Genetic Studies of Early-onset Dementia

Columbia University2 sites in 1 country1,000 target enrollmentSeptember 14, 2016

Overview

Phase
N/A
Intervention
Medical questionnaire
Conditions
Dementia, Early Onset
Sponsor
Columbia University
Enrollment
1000
Locations
2
Primary Endpoint
Genetic risk variants associated with early-onset dementia
Status
Recruiting
Last Updated
3 days ago

Overview

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 with Alzheimer's disease, mild cognitive impairment, other forms of dementia, as well as cognitively healthy individuals with a family history of dementia. Participants include males and females across all racial and ethnic groups.

Registry
clinicaltrials.gov
Start Date
September 14, 2016
End Date
April 30, 2028
Last Updated
3 days ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christiane Reitz, MD, PhD

Associate Professor of Neurology and Epidemiology

Columbia University

Eligibility Criteria

Inclusion Criteria

  • 35 years and older
  • Individuals experiencing memory concerns or diagnosed with dementia and their family members that are unrelated healthy controls without dementia.

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

Arms & Interventions

Dementia/Alzheimer's Disease

Individuals with Alzheimer's Disease or other dementia that began before age 70

Intervention: Medical questionnaire

Cognitively Healthy

Cognitively healthy individuals over the age of 35 years with a family history of dementia.

Intervention: Blood draw

Cognitively Healthy

Cognitively healthy individuals over the age of 35 years with a family history of dementia.

Intervention: Neurocognitive testing

Cognitively Healthy

Cognitively healthy individuals over the age of 35 years with a family history of dementia.

Intervention: Medical questionnaire

Mild Cognitive Impairment

Individuals with mild cognitive impairment that began before age 70

Intervention: Medical questionnaire

Dementia/Alzheimer's Disease

Individuals with Alzheimer's Disease or other dementia that began before age 70

Intervention: Blood draw

Dementia/Alzheimer's Disease

Individuals with Alzheimer's Disease or other dementia that began before age 70

Intervention: Neurocognitive testing

Mild Cognitive Impairment

Individuals with mild cognitive impairment that began before age 70

Intervention: Blood draw

Mild Cognitive Impairment

Individuals with mild cognitive impairment that began before age 70

Intervention: Neurocognitive testing

Early-onset dementia prior to the age of 65.

Individuals diagnosed with early-onset dementia prior to the age of 65.

Intervention: Blood draw

Early-onset dementia prior to the age of 65.

Individuals diagnosed with early-onset dementia prior to the age of 65.

Intervention: Neurocognitive testing

Early-onset dementia prior to the age of 65.

Individuals diagnosed with early-onset dementia prior to the age of 65.

Intervention: Medical questionnaire

Outcomes

Primary Outcomes

Genetic risk variants associated with early-onset dementia

Time Frame: 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

Time Frame: 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

Study Sites (2)

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