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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

Tracking Information
First Submitted Date July 27, 2018
First Posted Date August 24, 2018
Last Update Posted Date October 7, 2019
Actual Study Start Date June 16, 2017
Estimated Primary Completion Date June 16, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Onset Alzheimer's Disease Genomic Study
Official Title Early Onset Alzheimer's Disease Genomic Study
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and Plasma Specimens
Sampling Method Probability Sample
Study Population Patients with a diagnosis of early-onset Alzheimer's disease
Condition Alzheimer Disease
Intervention Genetic: Genetic Testing
A one time blood sample will be taken.
Study Groups/Cohorts
  • Early-Onset Alzheimer's disease
    Patients ages 45-60 with Early-Onset Alzheimer's disease
    Intervention: Genetic: Genetic Testing
  • Negative Control
    Family members of patients with Early-Onset Alzheimer's disease who have consented to the study.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2018)
2
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 16, 2022
Estimated Primary Completion Date June 16, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sarah B Burris, MHA 214-818-0382 Sarah.Burris@BSWHealth.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03645993
Other Study ID Numbers 017-176
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Baylor Research Institute
Study Sponsor Baylor Research Institute
Collaborators Translational Genomics Research Institute
Investigators Not Provided
PRS Account Baylor Research Institute
Verification Date October 2019