Hyperspectral Retinal Observations for the Cross-sectional Detection of Alzheimer's Disease

NCT05604183 | Unknown DMC

• 2 other identifiers: MANTIS_2022_08_CrossSect_BCIV-22-06-039726
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Two devices will be tested in this research:

1. 1.Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation).
2. 2.Blekinge CoGNIT cognitive ability test (i.e., an assessment).

Conditions

Alzheimer Disease, Early Onset; Cognitive Impairment; Cognitive Decline

Keywords

Retinoscopy; Non-invasive; Accessible healthcare

Outcome Measures

Primary Outcomes (4)

• Accuracy (Statistical metric) retinal image classification model

  Performance metric of the retinal image classification model: model accuracy \[percent\]

  within 2 months after last patient procedure

• Area under the Curve (statistical metrics) retinal image classification model

  Performance metric of the retinal image classification model: Area under the Curve (AuC) \[0 \< AuC \< 1\]

  within 2 months after last patient procedure

• Sensitivity (Statistical metric) retinal image classification model

  Performance metrics of the retinal image classification model: Sensitivity \[percent\]

  within 2 months after last patient procedure

• CoGNIT test diagnostic accuracy

  Accuracy \[percent\] of diagnosis based on the CoGNIT test data

  within 2 months after last patient procedure

Secondary Outcomes (4)

• Accuracy: Metrics combination model

  within 3 months after last patient procedure

• Area Under the Curve: Metrics combination model

  within 3 months after last patient procedure

• Sensitivity: Metrics combination model

  within 3 months after last patient procedure

• Non invasive test variability compared to reference

  within 3 months after last patient procedure

Other Outcomes (2)

• Adverse effect

  Immediately after the retinoscopy procedure

• Serious adverse effect

  Immediately after the retinoscopy procedure

Study Arms (1)

Subjects

EXPERIMENTAL

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.

Procedure: non-invasive hyperspectral retinoscopy; Procedure: blood sample; Diagnostic Test: Test of cognitive ability on tablet computer with CoGNIT software

Interventions

non-invasive hyperspectral retinoscopy PROCEDURE

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.

Also known as: eye-scan, fundus image (of the eye)

Subjects

blood sample PROCEDURE

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.

Also known as: draw blood

Subjects

Test of cognitive ability on tablet computer with CoGNIT software DIAGNOSTIC_TEST

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.

Also known as: CoGNIT test, Cognitive test, Mental ability test

Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subject age over 18 years old
• 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.

You may not qualify if:

• There are contra-indications for lumbar puncture (eg: brain tumor with suspicion of raised intracranial pressure, coagulopathies or ongoing anticoagulant medications) will be excluded from the study.
• When the subject suffers from excessive visual or auditive impairment, the he/she will be excluded from the CoGNIT track.

Sponsors & Collaborators

• Mantis Photonics AB: lead
• Blekinge Institute of Technology: collaborator
• Blekinge County Council Hospital: collaborator

Study Sites (2)

Blekinge Tekniska Högskola

Karlskrona, Blekine Län, 37141, Sweden

Location

Blekinge Hospital

Karlskrona, Blekinge County, 37141, Sweden

Location

Related Publications (8)

• 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.

  PMID: 35275064 BACKGROUND

• 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.

  PMID: 25279138 BACKGROUND

• 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.

  PMID: 30738407 BACKGROUND

• 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.

  PMID: 31843944 BACKGROUND

• 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.

  PMID: 31530809 BACKGROUND

• 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.

  PMID: 31920420 BACKGROUND

• 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.

  PMID: 34838239 BACKGROUND

• 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.

  PMID: 41153055 DERIVED

Related Links

• World Alzheimer Report 2022 - Alzheimer's disease international

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anders Behrens, MD, PhD

  Blekinge Tekniska Högskola

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Behrens, MD, PhD

CONTACT

+460702034496; anders.behrens@regionblekinge.se

Jan Alexander, Master

CONTACT

0478779156; jan.alexander@mantis-photonics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The diagnosis of Amyloidosis (biomarker of Alzheimer's disease) is made based on the normal patient care consisting of the neurologist assessment and the Cerebro-Spinal Fluid analysis. This diagnosis is used as golden standard for the model based on retinal images and cognitive test results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 3, 2022
• Study Start: November 1, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)