Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors

An observational study of Diabetes, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes
What is being tested?: Semaglutide and DPP-4 inhibitor
How many people: 742,670 participants
Where: 1 siteUnited States
Study dates: 30 Nov 2022to 31 Dec 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Study population: This study will employ a new user, active comparator, observational cohort study design comparing semaglutide v DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin). The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).

Who may be able to join

1. Aged >/= 65 years on the index date
2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
3. Diagnosis code for type 2 diabetes measured 365 days prior to drug initiation

Who cannot join

1. Prior history of dementia measured anytime prior to cohort entry date
2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
3. Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors
4. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham and Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

Read the detailed description

This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Conditions: Diabetes
Being tested: Semaglutide, DPP-4 inhibitor
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SemaglutideDrug
Semaglutide claim is used as the exposure group.
DPP-4 inhibitorDrug
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.

Study groups in NCT05768945
Study group	Role	What they receive
Semaglutide		Exposure group Receives: Drug: Semaglutide
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)		Reference group Receives: Drug: DPP-4 inhibitor

What is being measured

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

Time to Dementia Onset
Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations.
Measured: Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)

Timeline

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

30 Nov 202231 Dec 2023

First posted15 Mar 2023
Study start30 Nov 2022
Primary completion7 Jul 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
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: Retrospective
Enrolment: 742,670 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05768945
Sponsor's protocol ID: 2019P003607-14
Status last verified: Oct 2025
First submitted: 3 Mar 2023
Last updated: 10 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors
ClinicalTrials.gov ID: NCT05768945
Acronym / sponsor ID: 2019P003607-14
Conditions: Diabetes
Study type: Observational
Recruitment status: Completed
Enrolment: 742,670 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Rutgers University, Johns Hopkins University
Study start: 30 Nov 2022 (actual)
Primary completion: 7 Jul 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 15 Mar 2023 (actual)
Results: Posted 10 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Semaglutide	–	Drug: SemaglutideExposure group
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)	–	Drug: DPP-4 inhibitorReference group

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult
Study population: This study will employ a new user, active comparator, observational cohort study design comparing semaglutide v DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin). The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).

Key inclusion criteria (3 listed)

1. Aged >/= 65 years on the index date
2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
3. Diagnosis code for type 2 diabetes measured 365 days prior to drug initiation

Key exclusion criteria (4 listed)

1. Prior history of dementia measured anytime prior to cohort entry date
2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
3. Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors
4. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SemaglutideSemaglutide claim is used as the exposure group.	Drug	Semaglutide
DPP-4 inhibitorDPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.	Drug	DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)

Primary outcome

Time to Dementia Onset
Time frame: Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)
Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations.

Results and safety

Results posted to the registry on 10 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Semaglutide	9,073	7,129
DPP4 Inhibitors	733,597	7,129

Primary outcome: Time to Dementia Onset

Time frame: Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref). Number (95% Confidence Interval). Unit: Incidence rate per 1000 person year

Measure	Semaglutide n = 7129	DPP4 Inhibitors n = 7129
Analysis 1	4.40 (2.27 to 7.68)	6.06 (3.70 to 9.36)
Analysis 2	4.69 (1.28 to 12.02)	6.71 (2.70 to 13.83)
Analysis 3	2.80 (0.34 to 10.13)	10.24 (6.96 to 14.54)
Analysis 4	0.37 (0.01 to 2.04)	0.61 (0.07 to 2.19)

Population analysed: Study cohort after 1:1 propensity score matching

Adverse events

Time frame: 'As-treated' follow-up approach - Median follow-up days of 98 (for Semaglutide) and 134 (for DPP4 Inhibitors). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Semaglutide	0 of 0	0 of 7,129 (0%)	24 of 7,129
DPP4 Inhibitors	0 of 0	0 of 7,129 (0%)	44 of 7,129

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes

Not yet recruitingPhase 3
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Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Recruiting
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Recruiting
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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. This study is not recruiting at the moment.

Madhav Thambisetty, MD, PhD principal investigator

National Institute on Aging (NIA)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by Brigham and Women's Hospital at 1 site 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Dementia Onset (time frame: Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05768945.

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 10 Nov 2025.