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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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