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The Diabetes Prevention Program Outcomes Study AD/ADRD Project

Launched by MARINELLA TEMPROSA · Jan 19, 2023

Trial Information

Current as of October 25, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This is an observational study called the DPPOS AD/ADRD Project. It follows people who started with prediabetes or type 2 diabetes in the Diabetes Prevention Program to learn how these blood sugar conditions relate to thinking and memory problems, including dementia. Researchers will combine regular cognitive tests over several years with blood tests and brain imaging to see how brain changes line up with changes in thinking. The main goal is to classify each person’s thinking skills over time (normal, mild memory problems, or dementia) and to explore blood and brain markers that might be linked to those changes.

About who can be in the study: researchers expect to enroll around 1,900–2,000 people who were originally in the DPP and are still alive, most around age 72, with many women and a substantial portion from racial or ethnic minority groups. For brain imaging, participants must be 55 or older and able to have an MRI. Participants will have two visits to provide urine, plasma, and serum samples, plus ongoing cognitive testing; those in the brain-imaging group may have brain scans as part of the study. This is not a treatment trial—it’s a look at how prediabetes and diabetes relate to brain health, with data that will be shared with other researchers after the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All surviving participants originally randomized in the Diabetes Prevention Program
  • For Brain Imaging subcohort, only participants aged 55 years and older and those without contraindication to MRI will be included. Contraindications to MRI include the inability to lie flat, claustrophobia, and the presence of indwelling metallic objects, medical or non-medical, that are not 3T MRI compatible.
  • Exclusion Criteria:
  • -

About Marinella Temprosa

Marinella Temprosa is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative study designs and rigorous scientific methodologies. With a focus on various therapeutic areas, the organization collaborates with healthcare professionals, research institutions, and regulatory bodies to ensure the highest standards of ethical conduct and data integrity. Marinella Temprosa emphasizes transparency and patient safety in all its clinical trials, striving to contribute meaningful insights that enhance treatment options and foster advancements in healthcare.

Locations

Chicago, Illinois, United States

Boston, Massachusetts, United States

New York, New York, United States

New York, New York, United States

Chicago, Illinois, United States

Pittsburgh, Pennsylvania, United States

Bronx, New York, United States

Boston, Massachusetts, United States

Miami, Florida, United States

Indianapolis, Indiana, United States

Albuquerque, New Mexico, United States

Memphis, Tennessee, United States

Honolulu, Hawaii, United States

Saint Louis, Missouri, United States

Aurora, Colorado, United States

Philadelphia, Pennsylvania, United States

San Antonio, Texas, United States

Lutherville, Maryland, United States

Washington, District Of Columbia, United States

Baton Rouge, Louisiana, United States

Phoenix, Arizona, United States

Alhambra, California, United States

San Diego, California, United States

Washington, District Of Columbia, United States

Rockville, Maryland, United States

Shiprock, New Mexico, United States

Zuni, New Mexico, United States

Seattle, Washington, United States

Patients applied

0 patients applied

Trial Officials

Jose Luchsinger

Principal Investigator

Columbia University

David Nathan

Study Chair

Massachusetts General Hospital

Marinell Temprosa

Principal Investigator

George Washington University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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