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DiabetesDPPOS-4NCT05704309

The Diabetes Prevention Program Outcomes Study AD/ADRD Project

An observational study of Diabetes and Alzheimer Disease, run by Marinella Temprosa at 27 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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?… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Diabetes, Alzheimer Disease, Dementia, Vascular
How many people
1,976 participants
Where
27 sitesUnited States
Study dates
7 Nov 2022to 30 Aug 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

27 sites in 1 country

United States27 sites
  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • University of California Los Angeles

    Alhambra, California, 91801

  • University of Colorado

    Aurora, Colorado, 80045

  • Pennington Biomedical Center

    Baton Rouge, Louisiana, 70808

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • Indiana University

    Indianapolis, Indiana, 46202

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • University of Tennessee

    Memphis, Tennessee, 38103

  • University of Miami

    Miami, Florida, 33136

  • Columbia University Medical Center

    New York, New York, 10032

  • Columbia University

    New York, New York, 10032

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • SW American Indian Center - Phoenix

    Phoenix, Arizona, 85016

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Biostatistics Center, George Washington University

    Rockville, Maryland, 20852

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

  • University of California San Diego

    San Diego, California, 92128

  • University of Washington, VA Puget Sound Health Care System

    Seattle, Washington, 98108

  • SW American Indian Center - Shiprock

    Shiprock, New Mexico, 87420

  • Washington University

    St Louis, Missouri, 63110

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Medstar Health Research Institute

    Washington D.C., District of Columbia, 20003

  • SW American Indian Center - Zuni

    Zuni, New Mexico, 87327

Other trials in United States

About this study

Official title: Alzheimer's Disease and Alzheimer's Disease Related Dementias in Prediabetes and Type 2 Diabetes: The Diabetes Prevention Program Outcomes Study AD/ADRD Project

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.

Read the detailed description

DPPOS AD/ADRD focuses on one of the most important, complex questions in Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD) research: 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? Despite knowledge that persons with PreD and T2D are a high-risk group for cognitive decline, mild cognitive impairment (MCI), and dementia, the risk factors, mechanisms, and neuropathology of cognitive impairment in persons with PreD and T2D remain unclear. Gaps in knowledge on cognitive impairment in PreD and T2D include: (a) the role of AD and/or non-AD neuropathology beyond vascular contributions to cognitive impairment and dementia (VCID); (b) the role of glycemia, related metabolic factors such as hyperinsulinemia, and traditional micro and macrovascular complications of PreD/T2D; (c) the role of glucose-lowering medications, primarily metformin; and (d) the role of physical activity, physical function, and frailty, key in PreD and T2D. The 4 interrelated projects will address these gaps, leveraging the Diabetes Prevention Program (DPP) Outcomes Study (DPPOS) cohort and its detailed PreD/T2D phenotyping, adding state of the art AD/ADRD phenotyping. The DPPOS cohort currently has a mean age of 72 years, with 76% over the age of 65. Thus, the cohort is in a period of the lifespan when the development of cognitive decline, MCI, and dementia accelerates. This extensively phenotyped cohort represents an estimated 50 million Americans. To address this proposal's complex interrelated questions, the study has two waves of state-of-the-art AD/ADRD phenotyping during the proposed 5-year funding period, including comprehensive cognitive assessments and syndrome adjudication and plasma and brain imaging biomarkers of AD/ADRD. The study will address the complex overarching question of our project through the following aims: (1) To establish 5 cores to support the 4 integrated scientific projects: An Administrative Core, a Clinical Operations and Procedures Core, a Cognitive Assessment and Adjudication Core, a Neuroimaging and Plasma Biomarkers Core, and A Biostatistics and Data Infrastructure Core: (2) To conduct 4 integrated projects focused on key aspects of the central question of this proposal: Project 1 will examine the association of cognitive decline, MCI, and dementia in the DPPOS cohort with biomarkers of neuropathology and brain insulin signaling, and with sociodemographic and behavioral factors; Project 2 will examine the associations of cumulative glycemia, related metabolic factors, and microvascular and macrovascular complications, with cognitive syndromes and biomarkers of neuropathology; Project 3 will examine the association of cumulative exposure to metformin and other T2D medications with cognitive syndromes and biomarkers of neuropathology; Project 4 will evaluate the association of trajectories of physical activity, physical function and frailty with cognitive syndromes and biomarkers of neuropathology.

Medical subject headings
Diabetes Mellitus, Alzheimer Disease, Dementia, Vascular, Dementia, Prediabetic State

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Diagnoses

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

    Measured: Sept 2022 to October 2026

Secondary outcomes (7)
  1. ptau-181

    Plasma biomarkers for AD/ADRD

    Measured: Sept 2022 to October 2026

  2. Aβ42/40 ratio

    Plasma biomarkers for AD/ADRD

    Measured: Sept 2022 to October 2026

  3. Neurofilament Light Chain (NfL)

    Plasma biomarkers for AD/ADRD

    Measured: Sept 2022 to October 2026

  4. Glial fibrillary acidic protein (GFAP)

    Plasma biomarkers for AD/ADRD

    Measured: Sept 2022 to October 2026

  5. Amnestic cognitive decline

    Based on the SEVLT immediate recall (sum of trials 1-3) and delayed recall (trial 4)

    Measured: Sept 2022 to October 2026

  6. Non-amnestic cognitive decline

    DSST measure

    Measured: Sept 2022 to October 2026

  7. White matter microstructure

    Among ppts in the neuromaging subcohort

    Measured: March 2023 to October 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start7 Nov 2022
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,976 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05704309
Sponsor's protocol ID
DPPOS AD/ADRD
Other IDs
1U19AG078558
Acronym
DPPOS-4
Status last verified
Aug 2025
First submitted
11 Jan 2023
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will have data in the NACC (National Alzheimer's Coordinating Center) data repository for NACC UDS (Uniform Data Set) data and the rest will be available in the NIDDK data repostiory

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Alzheimer Disease, run by Marinella Temprosa at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Diagnoses (time frame: Sept 2022 to October 2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

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DPPOS-4 Clinical Trial NCT05704309 | AzTrials