Alzheimer DiseaseEarly Phase 1DPPOS-BrainNCT03757910
Brain Imaging in the Diabetes Prevention Program Outcomes Study
A Early Phase 1 study testing 18F-MK-6240 and 11C-PIB in people with Alzheimer Disease, run by José A. Luchsinger at 1 site in United States.
Trial summary
This is a cross-sectional pilot study of Alzheimer's disease (AD) brain imaging biomarkers in Diabetes Prevention Program (DPP) outcomes study (DPPOS) participants from the New York City sites (Columbia and Einstein), comparing 10 persons originally randomized to metformin and 10 persons randomized to placebo in DPP. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 18F-MK-6240 and 11C-PIB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Jan 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active participants in the Diabetes Prevention Program Outcomes Study (DPPOS) in New York City originally randomized to metformin or placebo
- 60 years and older
Who cannot join
- Known dementia
- Contraindications to magnetic resonance imaging (MRI)
- Contraindications to radio-contrast agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Amyloid Brain Positron Emission Tomography (PET) Imaging With 11C-PIB and Tau PET Imaging With 18F-MK-6240 in the Diabetes Prevention Program Outcomes Study.
This is a cross-sectional pilot study of Alzheimer's disease (AD) brain imaging biomarkers in Diabetes Prevention Program (DPP) outcomes study (DPPOS) participants from the New York City sites (Columbia and Einstein), comparing 10 persons originally randomized to metformin and 10 persons randomized to placebo in DPP. All study procedures will be conducted at Columbia University Irving Medical Center. Eligible participants will receive a PET scans and a brain MRI, which may be conducted in one, two, or three separate visits.
Read the detailed description
Hyperinsulinemia is believed to increase the risk of Alzheimer's dementia through both cerebrovascular and A related mechanisms, and this hypothesis has prompted testing strategies related to hyperinsulinemia and diabetes in the prevention and treatment of Alzheimer's dementia.These strategies usually entail improving insulin sensitivity to lower insulin and glucose levels, such as lifestyle (diet and exercise) and metformin, which were effective strategies for preventing diabetes in the DPPOS. There are conflicting data relating metformin with increased AD risk, and this needs to be clarified in DPPOS. Several laboratory and human studies have suggested that metformin increases the risk of Alzheimer's dementia, but this is countered by other studies indicating that it is beneficial. Preliminary data in humans and animals support the beneficial effects of metformin on Alzheimer's dementia risk.
- Conditions
- Alzheimer Disease
- Being tested
- 18F-MK-6240, 11C-PIB
- Keywords
- Metformin, Pre-diabetes, Type 2 diabetes, DPPOS
- Medical subject headings
- Alzheimer Disease, Glucose Intolerance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-MK-6240Drug
This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).
11C-PIBDrug
Also called 11C-Pittsburgh Compound B
This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.
| Study group | Role | What they receive |
|---|---|---|
| DPPOS Exposed to Metformin | Experimental | DPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB. Receives: Drug: 18F-MK-6240; Drug: 11C-PIB |
| DPPOS Exposed to Placebo | Active comparator | DPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB. Receives: Drug: 18F-MK-6240; Drug: 11C-PIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Amyloid SUVR
Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)
Measured: Up to 1 hour post-injection
Brain Tau SUVR
Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes
Measured: Up to 1 hour post-injection
Secondary outcomes (2)
Hippocampal Cortical Thickness
Thickness in the hippocampal cortex
Measured: Up to 1 hour post-injection
White Matter Hyper Intensity Volume
Volume of brain white matter hyper-intensities
Measured: Up to 1 hour post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Oct 2019
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: Difficulty recruiting due to the COVID-19 pandemic and end of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- José A. Luchsinger
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, George Washington University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor-investigator, José A. Luchsinger, Columbia University
- Investigators
- Jose A. Luchsinger, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757910
- Sponsor's protocol ID
- AAAS1176
- Other IDs
- 3U01DK048404-25S1
- Acronym
- DPPOS-Brain
- Status last verified
- Mar 2024
- First submitted
- 27 Nov 2018
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid Brain Positron Emission Tomography (PET) Imaging With 11C-PIB and Tau PET Imaging With 18F-MK-6240 in the Diabetes Prevention Program Outcomes Study.
- ClinicalTrials.gov ID
- NCT03757910
- Acronym / sponsor ID
- DPPOS-Brain / AAAS1176
- Conditions
- Alzheimer Disease
- Keywords
- Metformin, Pre-diabetes, Type 2 diabetes, DPPOS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting due to the COVID-19 pandemic and end of funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- José A. LuchsingerUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, George Washington University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 29 Nov 2018 (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.
This is a cross-sectional pilot study of Alzheimer's disease (AD) brain imaging biomarkers in Diabetes Prevention Program (DPP) outcomes study (DPPOS) participants from the New York City sites (Columbia and Einstein), comparing 10 persons originally randomized to metformin and 10 persons randomized to placebo in DPP. All study procedures will be conducted at Columbia University Irving Medical Center. Eligible participants will receive a PET scans and a brain MRI, which may be conducted in one, two, or three separate visits.
Detailed description
Hyperinsulinemia is believed to increase the risk of Alzheimer's dementia through both cerebrovascular and A related mechanisms, and this hypothesis has prompted testing strategies related to hyperinsulinemia and diabetes in the prevention and treatment of Alzheimer's dementia.These strategies usually entail improving insulin sensitivity to lower insulin and glucose levels, such as lifestyle (diet and exercise) and metformin, which were effective strategies for preventing diabetes in the DPPOS. There are conflicting data relating metformin with increased AD risk, and this needs to be clarified in DPPOS. Several laboratory and human studies have suggested that metformin increases the risk of Alzheimer's dementia, but this is countered by other studies indicating that it is beneficial. Preliminary data in humans and animals support the beneficial effects of metformin on Alzheimer's dementia risk.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPPOS Exposed to Metformin | Experimental | Drug: 18F-MK-6240, Drug: 11C-PIBDPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB. |
| DPPOS Exposed to Placebo | Active comparator | Drug: 18F-MK-6240, Drug: 11C-PIBDPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Active participants in the Diabetes Prevention Program Outcomes Study (DPPOS) in New York City originally randomized to metformin or placebo
- 60 years and older
Key exclusion criteria (3 listed)
- Known dementia
- Contraindications to magnetic resonance imaging (MRI)
- Contraindications to radio-contrast agents.
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 |
|---|---|---|
| 18F-MK-6240This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi). | Drug | DPPOS Exposed to Metformin, DPPOS Exposed to Placebo |
| 11C-PIBAlso: 11C-Pittsburgh Compound BThis radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi. | Drug | DPPOS Exposed to Metformin, DPPOS Exposed to Placebo |
Primary outcome
Brain Amyloid SUVR
Time frame: Up to 1 hour post-injection
Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)
Brain Tau SUVR
Time frame: Up to 1 hour post-injection
Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes
2 secondary outcomes
Hippocampal Cortical Thickness
Time frame: Up to 1 hour post-injection
White Matter Hyper Intensity Volume
Time frame: Up to 1 hour post-injection
Results and safety
The study was stopped early (reason given: Difficulty recruiting due to the COVID-19 pandemic and end of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
Not yet recruitingPhase 3
Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study
Alzheimer Disease
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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.
Jose A. Luchsinger, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-MK-6240 and 11C-PIB in people with Alzheimer Disease, run by José A. Luchsinger 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Mar 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty recruiting due to the COVID-19 pandemic and end of funding). Results are not available in the source record.
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?
Brain Amyloid SUVR (time frame: Up to 1 hour post-injection). The study lists 2 primary outcomes in all. 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 4 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.