Cognitive Impairment Clinical Trial
Official title:
Hyperspectral Retinal Observations for the Cross-sectional Detection of Alzheimer's Disease
Two devices will be tested in this research: 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).
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 29, 2023 |
Est. primary completion date | December 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Blekinge Hospital | Karlskrona | Blekinge Län |
Sweden | Blekinge Tekniska Högskola | Karlskrona | Blekine Län |
Lead Sponsor | Collaborator |
---|---|
Mantis Photonics AB | Blekinge County Council Hospital, Blekinge Institute of Technology |
Sweden,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Hadoux X, Hui F, Lim JKH, Masters CL, Pébay 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, Rhéaume 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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse effect | Measurement:
Percentage [percent] of patients who report adverse effects such as transient 'imprint' of the flash or other adverse effects. |
Immediately after the retinoscopy procedure | |
Other | Serious adverse effect | Occurence of serious adverse effects due to the procedure.
Any patient who suffers serious harm due to the procedure is a study outcome and a study endpoint. |
Immediately after the retinoscopy procedure | |
Primary | 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 | |
Primary | 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 | |
Primary | Sensitivity (Statistical metric) retinal image classification model | Performance metrics of the retinal image classification model: Sensitivity [percent] | within 2 months after last patient procedure | |
Primary | CoGNIT test diagnostic accuracy | Accuracy [percent] of diagnosis based on the CoGNIT test data | within 2 months after last patient procedure | |
Secondary | Accuracy: Metrics combination model | A combination model of both non-invasive techniques will be evaluated based on the same metrics as the single-technique model (see primary objectives) and evaluated based on the comparison of said metrics: accuracy [percent] for the optimal choice of threshold. | within 3 months after last patient procedure | |
Secondary | Area Under the Curve: Metrics combination model | A combination model of both non-invasive techniques will be evaluated based on the same metrics as the single-technique model (see primary objectives) and evaluated based on the comparison of said metrics: Area Under the Curve [0within 3 months after last patient procedure |
| |
Secondary | Sensitivity: Metrics combination model | A combination model of both non-invasive techniques will be evaluated based on the same metrics as the single-technique model (see primary objectives) and evaluated based on the comparison of said metrics: sensitivity [percent] for the optimal choice of threshold. | within 3 months after last patient procedure | |
Secondary | Non invasive test variability compared to reference | The variability [relative and normalized: percent] between the first and the second hyperspectral retinoscopy result will be compared to the variability between the blood analysis at the first and the second appointment [relative and normalized: percent]. The blood test variability will be used as a reference in this study. | within 3 months after last patient procedure |
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