Early Onset Alzheimer's Disease Genomic Study (TGen)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Genetic: Genetic Testing

Detailed Description

About 50 people will be asked to take part in this study at this location. This will include participants with early-onset AD and their parents and siblings. Participants will be asked to: Sign this consent form or have a Legally Authorized Representative sign and provide the participant' health history. The study staff will review the participant's medical history and test results to see if the participant can be part of this study, The study staff will need to know any over-the-counter or prescription drugs, vitamins, or herbs taken by the participant. The study staff will discuss what is required to be part of this study. Participants cannot take part in this study if they have: 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 consent. If the participant agrees to take part in this study, one 8mL blood sample (about 2 teaspoons) will be collected from them. If the participant is receiving a clinically indicated blood draw, the blood collections for this study will occur at the same time. Participants may be required to have a research-specific blood draw if they are not scheduled for a blood draw during a regularly scheduled visit.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Baylor Scott & White AT&T Memory Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early-Onset Alzheimer's disease; Patients ages 45-60 with Early-Onset Alzheimer's disease	Genetic: Genetic Testing; A one time blood sample will be taken.
Negative Control; Family members of patients with Early-Onset Alzheimer's disease who have consented to the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Translational Genomics Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): April 24, 2024
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Early-Onset Alzheimer's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Genetic Techniques; Genetic Services; Diagnostic Services; Genetic Testing
• Other Study ID Numbers: 017-176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No