Alzheimer DiseaseTGenNCT03645993
Early Onset Alzheimer's Disease Genomic Study
An observational study of Alzheimer Disease, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Genetic Testing
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2017to 24 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of early-onset Alzheimer's disease
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White AT&T Memory Center
Dallas, Texas, 75231
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Genetic Testing
- Keywords
- Early-Onset Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic TestingGenetic
A one time blood sample will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Early-Onset Alzheimer's disease | Patients ages 45-60 with Early-Onset Alzheimer's disease Receives: Genetic: Genetic Testing | |
| Negative Control | Family members of patients with Early-Onset Alzheimer's disease who have consented to the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start16 Jun 2017
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645993
- Sponsor's protocol ID
- 017-176
- Acronym
- TGen
- Status last verified
- Jan 2026
- First submitted
- 27 Jul 2018
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Onset Alzheimer's Disease Genomic Study
- ClinicalTrials.gov ID
- NCT03645993
- Acronym / sponsor ID
- TGen / 017-176
- Conditions
- Alzheimer Disease
- Keywords
- Early-Onset Alzheimer's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Translational Genomics Research Institute
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early-Onset Alzheimer's disease | – | Genetic: Genetic TestingPatients ages 45-60 with Early-Onset Alzheimer's disease |
| Negative Control | – | –Family members of patients with Early-Onset Alzheimer's disease who have consented to the study. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of early-onset Alzheimer's disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic TestingA one time blood sample will be taken. | Genetic | Early-Onset Alzheimer's disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers found in blood (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026; AzTrials last refreshed its copy on 3 Nov 2026.