Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers (NCT04794634) | Clinical Trial Compass
CompletedNot Applicable
Relationship Between Alzheimer Disease and Diminution of the Three Macular Nervous Retinal Layers
France55 participantsStarted 2021-01-13
Plain-language summary
Alzheimer disease is hard, long and expensive to diagnose. In order to help the clinician, a new biomarker in Alzheimer disease seems to be very useful. The retina, as a window of the brain, could offer a new way to diagnose this common disease. Indeed, a retinal atrophy could especially appear in Alzheimer disease. Besides, many aspects about retinal alteration, visual function and their link with the disease deserve to be more explored. So as to fill these gaps, a new study about retinal specificity in Alzheimer disease appears to be relevant.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients having a consultation in the Research and Resources Memory Center of Amiens (RRMC) ,
* patients registered in the Alzheimer National Bank and having an Alzheimer Disease based on NIA-AA (McKahnn2011)and IWG2 (Dubois et al, 2014) criteria or, having a Lewy body disease based on revised criteria of McKeith et al 2020
* patients having a complete neuropsychological evaluation including a visual inspection time.
* patients having a MMSE ≥ 18/30 so as to ensure a good homogeneity of the group and to have an adequate ocular exam's quality.
* patients having an available MRI in the CHU's database including a 3DT1 sequence
* patients having a visual acuity better than 5/10, spherical refraction of +/- 5D, an astigmatism \< 3D and an applanation IOP \<22mmHg
Exclusion Criteria:
* Any other neurocognitive disorder
* Any other optical neuropathy including glaucoma
* All kind of retinal disease (diabetic retinopathy, age-related macular degeneration…)
* Diabetes mellitus
* Uncontrolled hypertension blood pressure
* Any ophthalmological conditions interfering with a good ocular examination or OCT quality (cataract, corneal opacity..)
* Severe dementia preventing a good ophthalmological examination
* Not consenting patient
* Patient with guardianship or curatorship having symptoms preventing a good ophthalmological examination (agitation, unstable ocular fixation)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation of retinal nerve fibres layer (RNFL) thickness in AD patient compared to healthy and LMD patients
Timeframe: one day
2
Variation of ganglion cell layer (CGL) thickness in AD patient compared to healthy and LMD patients
Timeframe: one day
3
Variation of intern plexiform layer (IPL) thickness in AD patient compared to healthy and LMD patients