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Early Onset Alzheimer's Disease Genomic Study (TGen)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645993
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Translational Genomics Research Institute
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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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.

Condition or disease Intervention/treatment
Alzheimer Disease 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 Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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
Blood and Plasma Specimens

Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of early-onset Alzheimer's disease
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sarah B Burris, MHA 214-818-0382 Sarah.Burris@BSWHealth.org

Locations
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United States, Texas
Baylor Scott & White AT&T Memory Center Recruiting
Dallas, Texas, United States, 75231
Contact: Sarah B Burris, MHA         
Sponsors and Collaborators
Baylor Research Institute
Translational Genomics Research Institute
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor Research Institute:
Early-Onset Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders