Early Onset Alzheimer's Disease Genomic Study

NCT03645993 | Completed

• 1 other identifier: 017-176
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect samples from patients with Early-Onset Alzheimer's disease (AD) and their immediate family members for molecular analysis. Samples will be studied in order to understand how molecular changes in the body are related to the development of the disease. Researchers will study your DNA and RNA in order to help doctors diagnose, treat, and monitor people at risk of developing Early-Onset AD in the future.

Conditions

Alzheimer Disease

Keywords

Early-Onset Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Biomarkers found in blood

  Blood will be taken so that tests can be run to locate a biomarker that will help to diagnose and treat early-onset Alzheimer's disease.

  2 years

Study Arms (2)

Early-Onset Alzheimer's disease

Patients ages 45-60 with Early-Onset Alzheimer's disease

Genetic: Genetic Testing

Negative Control

Family members of patients with Early-Onset Alzheimer's disease who have consented to the study.

Interventions

Genetic Testing GENETIC

A one time blood sample will be taken.

Early-Onset Alzheimer's disease

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of early-onset Alzheimer's disease

You may qualify if:

• Diagnosis of early-onset Alzheimer's disease based on the NIA-AA diagnostic criteria as determined by the clinician. (Those patients with severe dementia due to Alzheimer's disease or who have impaired decisional capacity, may participate only if their legally authorized representative gives their consent.)
• Male and female patients ≥40 and ≤65 years of age.
• Parents and siblings of the participant with Alzheimer's disease.

You may not qualify if:

• Family history of early or late-onset Alzheimer's disease.
• Uncontrolled concurrent illness including psychiatric illness or situations that would limit compliance with the study requirements or the ability to willingly give written or verbal informed consent

Sponsors & Collaborators

• Baylor Research Institute: lead
• Translational Genomics Research Institute: collaborator

Study Sites (1)

Baylor Scott & White AT&T Memory Center

Dallas, Texas, 75231, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Plasma Specimens

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 24, 2018
• Study Start: June 16, 2017
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)