Early Onset Alzheimer's Disease Genomic Study (TGen)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03645993 |
Recruitment Status : Unknown
Verified October 2019 by Baylor Research Institute.
Recruitment status was: Recruiting
First Posted : August 24, 2018
Last Update Posted : October 7, 2019
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Condition or disease | Intervention/treatment |
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Alzheimer Disease | Genetic: Genetic Testing |
Study Type : | Observational |
Estimated Enrollment : | 2 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Early Onset Alzheimer's Disease Genomic Study |
Actual Study Start Date : | June 16, 2017 |
Estimated Primary Completion Date : | June 16, 2022 |
Estimated Study Completion Date : | June 16, 2022 |

Group/Cohort | Intervention/treatment |
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Early-Onset Alzheimer's disease
Patients ages 45-60 with Early-Onset Alzheimer's disease
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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.
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- Biomarkers found in blood [ Time Frame: 2 years ]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.
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645993
Contact: Sarah B Burris, MHA | 214-818-0382 | Sarah.Burris@BSWHealth.org |
United States, Texas | |
Baylor Scott & White AT&T Memory Center | Recruiting |
Dallas, Texas, United States, 75231 | |
Contact: Sarah B Burris, MHA |
Responsible Party: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT03645993 |
Other Study ID Numbers: |
017-176 |
First Posted: | August 24, 2018 Key Record Dates |
Last Update Posted: | October 7, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Early-Onset Alzheimer's disease |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |