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.
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
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.
- Conditions
- Diabetes, Alzheimer Disease, Dementia, Vascular, Dementia, PreDiabetes
- 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.
Cognitive Diagnoses
Classification of normal, mild cognitive impairment or dementia based on NACC UDS
Measured: Sept 2022 to October 2026
Secondary outcomes (7)
ptau-181
Plasma biomarkers for AD/ADRD
Measured: Sept 2022 to October 2026
Aβ42/40 ratio
Plasma biomarkers for AD/ADRD
Measured: Sept 2022 to October 2026
Neurofilament Light Chain (NfL)
Plasma biomarkers for AD/ADRD
Measured: Sept 2022 to October 2026
Glial fibrillary acidic protein (GFAP)
Plasma biomarkers for AD/ADRD
Measured: Sept 2022 to October 2026
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
Non-amnestic cognitive decline
DSST measure
Measured: Sept 2022 to October 2026
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.
- First posted30 Jan 2023
- Study start7 Nov 2022
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marinella Temprosa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Marinella Temprosa, George Washington University
- Investigators
- Jose Luchsinger, Principal investigator, Columbia UniversityDavid Nathan, Study chair, Massachusetts General HospitalMarinell Temprosa, Principal investigator, George Washington University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05704309
- Acronym / sponsor ID
- DPPOS-4 / DPPOS AD/ADRD
- Conditions
- Diabetes, Alzheimer Disease, Dementia, Vascular, Dementia, PreDiabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,976 participants (estimated)
- Lead sponsor
- Marinella TemprosaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Diagnoses
Time frame: Sept 2022 to October 2026
Classification of normal, mild cognitive impairment or dementia based on NACC UDS
7 secondary outcomes
ptau-181
Time frame: Sept 2022 to October 2026
Aβ42/40 ratio
Time frame: Sept 2022 to October 2026
Neurofilament Light Chain (NfL)
Time frame: Sept 2022 to October 2026
Glial fibrillary acidic protein (GFAP)
Time frame: Sept 2022 to October 2026
Amnestic cognitive decline
Time frame: Sept 2022 to October 2026
Non-amnestic cognitive decline
Time frame: Sept 2022 to October 2026
White matter microstructure
Time frame: March 2023 to October 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Luchsinger principal investigator
Columbia University
David Nathan study chair
Massachusetts General Hospital
Marinell Temprosa principal investigator
George Washington University
27 sites in 1 country: see every site and its status.
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.