NCT05704309: DPPOS-4

The Diabetes Prevention Program Outcomes Study AD/ADRD Project

ENROLLING BY INVITATION Last updated 26 August 2025

What this trial tests

trial in Diabetes in 1,976 participants. Enrolling by invitation.

Timeline

7 November 2022

Primary endpoint
31 January 2027

30 August 2027

Quick facts

Lead sponsor	Marinella Temprosa
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	1,976
Start date	7 November 2022
Primary completion	31 January 2027
Estimated completion	30 August 2027
Sites	27 locations across United States

Conditions studied

• Diabetes — all drugs for Diabetes →
• Alzheimer Disease — all drugs for Alzheimer Disease →
• Dementia, Vascular — all drugs for Dementia, Vascular →
• Dementia — all drugs for Dementia →

Sponsor

Marinella Temprosa

Who can join

Eligibility, any sex, with Diabetes or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Diabetes Prevention Program and Its Outcomes Study: NIDDK's Journey Into the Prevention of Type 2 Diabetes and Its Public Health Impact.
   Crandall JP, Dabelea D, Knowler WC, Nathan DM, et al · · 2025 · cited 12× · PMID 40272279 · DOI 10.2337/dc25-0014
2. Beta cells to brain cells: The pivotal role of insulin and glucose metabolism in Alzheimer's disease.
   Schwartz SS, Rhea EM, Banks WA, Herman ME. · · 2025 · cited 3× · PMID 41383947 · DOI 10.1002/nep3.70008
3. The association of insulin responses and insulin sensitivity with cognition in adults with pre-diabetes: The Diabetes Prevention Program Outcomes Study.
   Shapiro ALB, Tjaden AH, Edelstein SL, Kahn SE, et al · · 2024 · cited 2× · PMID 38701667 · DOI 10.1016/j.jdiacomp.2024.108764
4. Sociodemographic, Clinical, and Psychosocial Predictors of Short- and Long-term Study Retention in the Diabetes Prevention Program (DPP) Outcomes Study (DPPOS).
   Tjaden AH, Braffett BH, Butera NM, Araneta MR, et al · · 2025 · cited 1× · PMID 40541257 · DOI 10.2337/dc25-0520
5. The 2018 World Cancer Research Fund/American Institute for Cancer Research Score and Cancer Risk: results from the diabetes prevention program outcomes study.
   Tjaden AH, Goldbaum AA, Edelstein SL, Heckman-Stoddard BM, et al · · 2025 · PMID 40675492 · DOI 10.1016/j.ajcnut.2025.07.011
6. Nonglycemic and Glycemic Risk Factors for Painful Neuropathic Symptoms and for Distal Symmetrical Polyneuropathy (DSPN) in the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study.
   Herman WH, Ciarleglio A, Callaghan BC, Edelstein SL, et al · · 2025 · PMID 40532190 · DOI 10.2337/dc25-0596