Cognitive DysfunctionNCT07254234
A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease
An observational study of Cognitive Dysfunction and Memory Disorders, run by Eli Lilly and Company at 3 sites in United Arab Emirates.
Trial summary
The purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues. For each participant, the study will last up to one month and requires one visit to the research site. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cognitive Dysfunction, Memory Disorders
- What is being tested?
- Retinal scan and Blood test
- How many people
- 200 participants
- Where
- 3 sitesUnited Arab Emirates
- Study dates
- 23 Sep 2026to Sep 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emiratis age 55 or older with mild memory complaints or MCI who are otherwise healthy.
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation, including medical history and physical examination.
- Have mild memory complaints or a diagnosis of mild cognitive impairment.
- Have undergone genotyping for apolipoprotein E (APOE) and are willing to make results available to the investigator.
- Montreal Cognitive Assessment (MoCA) score of greater than or equal to 22 and less than or equal to 28.
Who cannot join
- Have any medical condition that, in the opinion of the investigator, would be a contraindication to participation in the study.
- Have an existing diagnosis of AD or other dementia.
- Have contradictions to or an allergy to the ophthalmic dilating agents.
- Have known diagnosis of severe glaucoma or severe cataracts; have a significant refractive error (more than 12 diopters [D] of spherical equivalent refraction); or have any ocular media opacity that prevents imaging of the retina (that is, severe cataract). Note: mild to moderate cataracts or vision correction with glasses or contact lenses are not exclusion criteria.
- Current or previous treatment with anti-amyloid medications.
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United Arab Emirates3 sites, 3 recruiting
- Not yet recruiting
Burjeel Medical City
Abu Dhabi
Farah Negadi
- Recruiting
Sheikh Shakhbout Medical City
Abu Dhabi
Isam Saleh
- Recruiting
Sheikh Tahnoon Bin Mohammed Medical City
Abu Dhabi
Ali Hassan
About this study
Official title: Exploratory Study to Assess Utility of RetiSpec Artificial Intelligence Powered Retinal Imaging Solution in Detecting Amyloid Pathology in United Arab Emirates Nationals With Mild Impairment of Cognition
The purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues. For each participant, the study will last up to one month and requires one visit to the research site.
- Conditions
- Cognitive Dysfunction, Memory Disorders
- Being tested
- Retinal scan, Blood test
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal scanOther
Detailed image of the retina.
Blood testOther
Sample will be used to test for a specific form of a protein in the blood to learn more about early detection of Alzheimer's disease.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Memory Complaints or Mild Cognitive Impairment (MCI) | Retinal scan and blood biomarker testing Receives: Other: Retinal scan; Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with the Same Results on the Blood Test and Retinal Scan
Measured: Day 1
Secondary outcomes (1)
Percentage of Participants who Report High or Moderate Satisfaction with Retinal Scan
Measured by 5-item retinal scan feedback survey. Participants rate their experience with the retinal scan on a 5-item Likert scale that ranges from "Strongly Disagree" to "Strongly Agree." Higher scores are better.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start23 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254234
- Sponsor's protocol ID
- 27414
- Other IDs
- H7I-MC-S035
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess Utility of RetiSpec Artificial Intelligence Powered Retinal Imaging Solution in Detecting Amyloid Pathology in United Arab Emirates Nationals With Mild Impairment of Cognition
- ClinicalTrials.gov ID
- NCT07254234
- Acronym / sponsor ID
- 27414
- Conditions
- Cognitive Dysfunction, Memory Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 28 Nov 2025 (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 purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues. For each participant, the study will last up to one month and requires one visit to the research site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Memory Complaints or Mild Cognitive Impairment (MCI) | – | Other: Retinal scan, Other: Blood testRetinal scan and blood biomarker testing |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emiratis age 55 or older with mild memory complaints or MCI who are otherwise healthy.
Key inclusion criteria (4 listed)
- Participants who are overtly healthy as determined by medical evaluation, including medical history and physical examination.
- Have mild memory complaints or a diagnosis of mild cognitive impairment.
- Have undergone genotyping for apolipoprotein E (APOE) and are willing to make results available to the investigator.
- Montreal Cognitive Assessment (MoCA) score of greater than or equal to 22 and less than or equal to 28.
Key exclusion criteria (6 listed)
- Have any medical condition that, in the opinion of the investigator, would be a contraindication to participation in the study.
- Have an existing diagnosis of AD or other dementia.
- Have contradictions to or an allergy to the ophthalmic dilating agents.
- Have known diagnosis of severe glaucoma or severe cataracts; have a significant refractive error (more than 12 diopters [D] of spherical equivalent refraction); or have any ocular media opacity that prevents imaging of the retina (that is, severe cataract). Note: mild to moderate cataracts or vision correction with glasses or contact lenses are not exclusion criteria.
- Current or previous treatment with anti-amyloid medications.
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 |
|---|---|---|
| Retinal scanDetailed image of the retina. | Other | Participants with Memory Complaints or Mild Cognitive Impairment (MCI) |
| Blood testSample will be used to test for a specific form of a protein in the blood to learn more about early detection of Alzheimer's disease. | Other | Participants with Memory Complaints or Mild Cognitive Impairment (MCI) |
Primary outcome
Percentage of Participants with the Same Results on the Blood Test and Retinal Scan
Time frame: Day 1
1 secondary outcome
Percentage of Participants who Report High or Moderate Satisfaction with Retinal Scan
Time frame: Day 1
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 24 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Dysfunction and Memory Disorders, run by Eli Lilly and Company at 3 sites in United Arab Emirates.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Arab Emirates. 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?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with the Same Results on the Blood Test and Retinal Scan (time frame: Day 1). 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 24 Sep 2026.