The Diabetes Prevention Program Outcomes Study AD/ADRD Project

NCT05704309 | Enrolling By Invitation

• 2 other identifiers: DPPOS AD/ADRD1U19AG078558
• Study Type: observational
• Target: 1,976
• Locations: 1 country
• Sites: 27

Brief Summary

The DPPOS AD/ADRD project will address the overarching question: What are the determinants and the nature of cognitive impairment among persons with pre-diabetes (PreD) and type 2 diabetes (T2D), who are a high-risk group for cognitive impairment and represent a large fraction of the United States (US) population? This U19 proposal addresses the National Alzheimer's Project Act goal to "prevent, halt, or reverse AD" in the high-risk group of persons with pre-diabetes and type 2 diabetes, who represent over half of the population aged 60 years and older in the US.

Conditions

Diabetes; Alzheimer Disease; Dementia, Vascular; Dementia; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Cognitive Diagnoses

  Classification of normal, mild cognitive impairment or dementia based on NACC UDS

  Sept 2022 to October 2026

Secondary Outcomes (7)

• ptau-181

  Sept 2022 to October 2026

• Aβ42/40 ratio

  Sept 2022 to October 2026

• Neurofilament Light Chain (NfL)

  Sept 2022 to October 2026

• Glial fibrillary acidic protein (GFAP)

  Sept 2022 to October 2026

• Amnestic cognitive decline

  Sept 2022 to October 2026

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The DPPOS (2002-2022) is a 25-center observational study that started as the DPP randomized controlled clinical trial (1996-2001). The DPP demonstrated the ability to reduce the development of T2D with intensive lifestyle or metformin compared with placebo among persons with PreD. The combined DPP and DPPOS have followed the original DPP cohort for a mean of 23 (range 21-25) years as of 2022. For this project, we expect that the cohort will have 1979 participants, with approximately two thirds with T2D of precisely known duration. Forty-eight percent of the cohort are ethnic and racial minorities that are at relatively higher risk of AD/ADRD compared with non-Hispanic whites, and 71% are women.

You may qualify if:

• 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.

Sponsors & Collaborators

• Marinella Temprosa: lead
• National Institute on Aging (NIA): collaborator

Study Sites (27)

SW American Indian Center - Phoenix

Phoenix, Arizona, 85016, United States

Location

University of California Los Angeles

Alhambra, California, 91801, United States

Location

University of California San Diego

San Diego, California, 92128, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Medstar Health Research Institute

Washington D.C., District of Columbia, 20003, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Pennington Biomedical Center

Baton Rouge, Louisiana, 70808, United States

Location

Johns Hopkins University

Lutherville, Maryland, 21093, United States

Location

Biostatistics Center, George Washington University

Rockville, Maryland, 20852, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

SW American Indian Center - Shiprock

Shiprock, New Mexico, 87420, United States

Location

SW American Indian Center - Zuni

Zuni, New Mexico, 87327, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee

Memphis, Tennessee, 38103, United States

Location

University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

University of Washington, VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Links

• Study website

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens for urine, plasma and serum stored and banked from 2 visits

MeSH Terms

Conditions

Diabetes Mellitus; Alzheimer Disease; Dementia, Vascular; Dementia; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose Luchsinger

  Columbia University

  PRINCIPAL INVESTIGATOR

• David Nathan

  Massachusetts General Hospital

  STUDY CHAIR

• Marinell Temprosa

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 30, 2023
• Study Start: November 7, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: NACC 2025 and 2027 NIDDK repository 2027
• Access Criteria: Available to public by application

Locations

US (27)