Hyperspectral Retinal Observations for the Cross-sectional Detection of Alzheimer's Disease
NCT ID: NCT05604183
Last Updated: 2022-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2022-11-30
2023-12-29
Brief Summary
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1. Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation).
2. Blekinge CoGNIT cognitive ability test (i.e., an assessment).
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Detailed Description
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Strong indications of the possibility of classifying Alzheimer's status based on hyperspectral scans of the retina have been published by different researchers. These results were obtained based on images taken with hyperspectral cameras with a different working principle than the Mantis Photonics camera. The working principle of the Mantis Photonics camera allows making a hyperspectral retinoscopy with the same spectral range and comparable or better spectral resolution with a machine that is more modular and lower in cost. There is thus reason to hypothesize retinal scans taken with the Mantis Photonics camera can be used for the same classification task.
Previous studies on the automated tablet computer cognitive test CoGNIT have established validity, reliability and sensitivity for testing patients with Normal Pressure Hydrocephalus (NPH) . Recently feasibility of testing in Mild Cognitive Impairment (MCI) was affirmed (Behrens, Berglund, \& Anderberg, CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study, 2022). In NPH patients, CoGNIT was more sensitive to cognitive impairment at baseline and cognitive improvement after shunt surgery than the Mini-Mental State Examination (MMSE).
Blood tests for amyloid-β and other biomarkers related to Alzheimer's disease are being investigated for clinical practice, but the technique is not accepted as a standard test. Research has shown that renal function influences amyloid-β clearance from the body. Also, analytical errors influence test results. Therefore, one can question the influence of normal repeatability of the blood test result.
The aim of this investigation is the evaluation, (further) development and comparison of non-invasive techniques for the evaluation of patients suffering mild cognitive impairment, in particular, the Mantis Photonics hyperspectral camera with classification machine learning model in combination with the CoGNIT test of Dr Behrens (Blekinge Tekniska Högskola). These techniques will be compared to the result of cerebrospinal fluid analysis (CSF), the reference biological diagnostic technique for Alzheimer's disease.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
This diagnosis is used as golden standard for the model based on retinal images and cognitive test results.
Study Groups
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Subjects
On all subjects included in the study (see inclusion / exclusion criteria and informed consent) both procedures will be performed.
The result of these procedures (retinal scan, result from cognitive test and blood sample) will be used to build diagnostic classification models.
non-invasive hyperspectral retinoscopy
The Principal Investigator or a trained medical nurse (under the supervision of the principal investigator) will take an image of the retina of the patient with the Mantis Photonics hyperspectral retinoscopy camera.
blood sample
The Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will draw a small blood sample according to the standard medical procedures for drawing blood samples.
Test of cognitive ability on tablet computer with CoGNIT software
The Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will give the patient to perform the digital cognitive test on a commercial tablet computer. The Principal Investigator or the medical nurse will be available for the patient to ask questions while the test is ongoing.
Interventions
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non-invasive hyperspectral retinoscopy
The Principal Investigator or a trained medical nurse (under the supervision of the principal investigator) will take an image of the retina of the patient with the Mantis Photonics hyperspectral retinoscopy camera.
blood sample
The Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will draw a small blood sample according to the standard medical procedures for drawing blood samples.
Test of cognitive ability on tablet computer with CoGNIT software
The Principle Investigator or a trained medical nurse (under the supervision of the Principal Investigator) will give the patient to perform the digital cognitive test on a commercial tablet computer. The Principal Investigator or the medical nurse will be available for the patient to ask questions while the test is ongoing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The subject has undergone a lumbar puncture an cerebrospinal fluid analysis as part of the standard care.
* The subject has at least one healthy eye.
* The subject is applicable for taking a blood sample for the blood analysis test.
* The informed consent is provided, explained and understood by the person. The person has consented to the informed consent.
Exclusion Criteria
* When the subject suffers from excessive visual or auditive impairment, the he/she will be excluded from the CoGNIT track.
18 Years
ALL
No
Sponsors
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Blekinge Institute of Technology
OTHER
Blekinge County Council Hospital
OTHER
Mantis Photonics AB
INDUSTRY
Responsible Party
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Principal Investigators
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Anders Behrens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Blekinge Tekniska Högskola
Locations
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Blekinge Tekniska Högskola
Karlskrona, Blekine Län, Sweden
Blekinge Hospital
Karlskrona, Blekinge County, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Behrens A, Berglund JS, Anderberg P. CoGNIT Automated Tablet Computer Cognitive Testing in Patients With Mild Cognitive Impairment: Feasibility Study. JMIR Form Res. 2022 Mar 11;6(3):e23589. doi: 10.2196/23589.
Behrens A, Eklund A, Elgh E, Smith C, Williams MA, Malm J. A computerized neuropsychological test battery designed for idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2014 Sep 25;11:22. doi: 10.1186/2045-8118-11-22. eCollection 2014.
Behrens A, Elgh E, Leijon G, Kristensen B, Eklund A, Malm J. The Computerized General Neuropsychological INPH Test revealed improvement in idiopathic normal pressure hydrocephalus after shunt surgery. J Neurosurg. 2019 Feb 8;132(3):733-740. doi: 10.3171/2018.10.JNS18701. Print 2020 Mar 1.
Budelier MM, Bateman RJ. Biomarkers of Alzheimer Disease. J Appl Lab Med. 2020 Jan 1;5(1):194-208. doi: 10.1373/jalm.2019.030080.
Hadoux X, Hui F, Lim JKH, Masters CL, Pebay A, Chevalier S, Ha J, Loi S, Fowler CJ, Rowe C, Villemagne VL, Taylor EN, Fluke C, Soucy JP, Lesage F, Sylvestre JP, Rosa-Neto P, Mathotaarachchi S, Gauthier S, Nasreddine ZS, Arbour JD, Rheaume MA, Beaulieu S, Dirani M, Nguyen CTO, Bui BV, Williamson R, Crowston JG, van Wijngaarden P. Non-invasive in vivo hyperspectral imaging of the retina for potential biomarker use in Alzheimer's disease. Nat Commun. 2019 Sep 17;10(1):4227. doi: 10.1038/s41467-019-12242-1.
Rasmussen J, Langerman H. Alzheimer's Disease - Why We Need Early Diagnosis. Degener Neurol Neuromuscul Dis. 2019 Dec 24;9:123-130. doi: 10.2147/DNND.S228939. eCollection 2019.
Teunissen CE, Verberk IMW, Thijssen EH, Vermunt L, Hansson O, Zetterberg H, van der Flier WM, Mielke MM, Del Campo M. Blood-based biomarkers for Alzheimer's disease: towards clinical implementation. Lancet Neurol. 2022 Jan;21(1):66-77. doi: 10.1016/S1474-4422(21)00361-6. Epub 2021 Nov 24.
Dallora AL, Alexander J, Palesetti PP, Guenot D, Selvander M, Berglund JS, Behrens A. Hyperspectral retinal imaging to detect Alzheimer's disease in a memory clinic setting. Alzheimers Res Ther. 2025 Oct 28;17(1):232. doi: 10.1186/s13195-025-01887-4.
Related Links
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World Alzheimer Report 2022 - Alzheimer's disease international
Other Identifiers
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CIV-22-06-039726
Identifier Type: OTHER
Identifier Source: secondary_id
MANTIS_2022_08_CrossSect_B
Identifier Type: -
Identifier Source: org_study_id
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