Detecting an MCI and Amyloid Digital Neuro Signature(DNS) Using Altoida's Multimodal Digital Biomarkers.

NCT06223438 | Completed

• 1 other identifier: MCI-Amyloid-DNS-GT-001
• Study Type: observational
• Target: 614
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish multiple points of clinical validity for the Altoida digital biomarker assessment in individuals with a clinical diagnosis of cognitively normal (CN) and Mild Cognitive Impairment (MCI). Participants will use the Altoida app and the de-identified sensor data captured by the device will be used to train specific machine-learning algorithms to recognize early symptoms of cognitive decline, such as MCI or MCI with likelihood of amyloid pathology, as measured by digital biomarkers (T1 - Visit 1). Participants will be invited for an additional visit to evaluate test-retest reliability (T1' - Visit 2). Optionally, an updated variation of the Altoida app will be tested over the course of two additional visits to ensure optimal digital assessment delivery based on best practices in neuropsychological testing, user experience design, and data collection integrity (T2 - Visit 3 and T2' - Visit 4).

Conditions

Alzheimer Disease; MCI

Keywords

Augmented reality; Machine learning; MCI; Amyloid pathology; Alzheimer's disease; biomarkers; diagnosis

Outcome Measures

Primary Outcomes (1)

• training and reinforcing a specific ML algorithm

  Attainment of ROC-area under the curve (AUC) of atleast 0.75-0.80 for the identification of MCI vs CN

  6 months

Study Arms (2)

Cognitively normal (CN)

Participants must have an MMSE score of ≥26 and meet clinical criteria for cognitively normal based on National Institute of Aging (NIA) criteria verified in medical records or clinical assessment at first visit; ● Based on the judgment of the site PI, no evidence of functional decline based on the Functional Activities Questionnaire (FAQ) or equivalent assessment;

Mild Cognitive Impairment (MCI) with known amyloid status.

Cognitive concern, reflecting a change in cognition reported by the participant, informant (family member, caregiver), or clinician; * Participants must have an MMSE score of ≥24 and meet clinical criteria for MCI based on National Institute of Aging (NIA) criteria and verified through medical records or clinical evaluation at first visit; * Based on the judgment of the site PI, minimal to mild functional impairment but with preservation of independence in functional abilities based on the Functional Activities Questionnaire (FAQ) or equivalent assessment;

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified as cognitively unimpaired or with MCI by a clinical diagnosis with defined adjudication criteria. For biomarker status determination, participants can be enrolled with a historical positive amyloid status assessment result through CSF analysis or amyloid-PET testing up to 18 months before the Altoida assessment. Historical amyloid negative data can be accepted up to 6-12 months before the Altoida assessment if MMSE\>26. There will be at least 668 participants (334 CN; 334 MCI) (50+ years), enrolled globally across approximately six sites balanced for amyloid status (positive/negative). Underrepresented populations will be targeted with the goal of also maintaining an equal balance of males and females.

You may qualify if:

• Participants must provide written informed consent in the EC/IRB-approved informed consent form or have a Legally Authorized Representative (LAR) provide written consent on the participant's behalf;
• Male or female, 50+ years at the time of consent;
• Participants must be willing to comply with all study procedures as outlined in the informed consent;
• Fluency in the language of the tests used at the study site;
• At least four years of formal education (from primary school onwards);
• Adequate vision to complete the Altoida assessment and neuropsychological tests with or without corrective lenses;
• Have undisturbed locomotion;
• Participants should have, when available, an amyloid status assessment result (positive or negative) through CSF analysis or amyloid-PET testing. Historical positive amyloid data is accepted up to 18 months before taking the Altoida assessment. Historical amyloid negative data can be accepted up to 6-12 months before the Altoida assessment if MMSE\>26. If historical amyloid data is unavailable, determining amyloid status will be an optional component of the study protocol. The decision to include this assessment and the specific method employed will be collaboratively discussed and decided upon between the study sponsor and the respective study site;
• Optionally, participants might present, when available, a historical APOE, APP/PSEN1/2 genotype determination, and/or historical MRI/CT scan results relevant to clinical diagnosis.

You may not qualify if:

• ● Participants who have participated in a clinical trial longer than six months of any potential disease-modifying anti-amyloid AD treatment and remained active in the study for a duration of 6 or more months (i.e., continued receiving treatment);
• Participants who, in the opinion of the Site Principal Investigator, have serious or unstable medical conditions that would prohibit their completion of all study procedures and data collection or that would preclude their participation;
• Participants undergoing anticoagulant treatment or other blood dyscrasias, only if they need to undergo lumbar puncture for the assessment of amyloid pathology;
• Participants with a history of stroke or seizures within one year of study start;
• Participants with a history of chemotherapy within the past five years, or any type of malignancy or cancer that might interfere with the completion of the study, except for non-melanoma skin cancer or prostate cancer in situ;
• Participants with restrictions of performing physical activities or who are not ambulatory;
• Participants who have previously been enrolled in a study using the Altoida assessment

Sponsors & Collaborators

• Altoida: lead

Study Sites (1)

K2 Medical Research South Orlando

Orlando, Florida, 34711, United States

Location

Related Publications (7)

• Ohman F, Hassenstab J, Berron D, Scholl M, Papp KV. Current advances in digital cognitive assessment for preclinical Alzheimer's disease. Alzheimers Dement (Amst). 2021 Jul 20;13(1):e12217. doi: 10.1002/dad2.12217. eCollection 2021.

  PMID: 34295959 BACKGROUND

• Harms RL, Ferrari A, Meier IB, Martinkova J, Santus E, Marino N, Cirillo D, Mellino S, Catuara Solarz S, Tarnanas I, Szoeke C, Hort J, Valencia A, Ferretti MT, Seixas A, Santuccione Chadha A. Digital biomarkers and sex impacts in Alzheimer's disease management - potential utility for innovative 3P medicine approach. EPMA J. 2022 Jun 6;13(2):299-313. doi: 10.1007/s13167-022-00284-3. eCollection 2022 Jun.

  PMID: 35719134 BACKGROUND

• Buegler M, Harms R, Balasa M, Meier IB, Exarchos T, Rai L, Boyle R, Tort A, Kozori M, Lazarou E, Rampini M, Cavaliere C, Vlamos P, Tsolaki M, Babiloni C, Soricelli A, Frisoni G, Sanchez-Valle R, Whelan R, Merlo-Pich E, Tarnanas I. Digital biomarker-based individualized prognosis for people at risk of dementia. Alzheimers Dement (Amst). 2020 Aug 19;12(1):e12073. doi: 10.1002/dad2.12073. eCollection 2020.

  PMID: 32832589 BACKGROUND

• Jack CR Jr, Wiste HJ, Vemuri P, Weigand SD, Senjem ML, Zeng G, Bernstein MA, Gunter JL, Pankratz VS, Aisen PS, Weiner MW, Petersen RC, Shaw LM, Trojanowski JQ, Knopman DS; Alzheimer's Disease Neuroimaging Initiative. Brain beta-amyloid measures and magnetic resonance imaging atrophy both predict time-to-progression from mild cognitive impairment to Alzheimer's disease. Brain. 2010 Nov;133(11):3336-48. doi: 10.1093/brain/awq277. Epub 2010 Oct 8.

  PMID: 20935035 BACKGROUND

• Hu Y, Kirmess KM, Meyer MR, Rabinovici GD, Gatsonis C, Siegel BA, Whitmer RA, Apgar C, Hanna L, Kanekiyo M, Kaplow J, Koyama A, Verbel D, Holubasch MS, Knapik SS, Connor J, Contois JH, Jackson EN, Harpstrite SE, Bateman RJ, Holtzman DM, Verghese PB, Fogelman I, Braunstein JB, Yarasheski KE, West T. Assessment of a Plasma Amyloid Probability Score to Estimate Amyloid Positron Emission Tomography Findings Among Adults With Cognitive Impairment. JAMA Netw Open. 2022 Apr 1;5(4):e228392. doi: 10.1001/jamanetworkopen.2022.8392.

  PMID: 35446396 BACKGROUND

• Alcolea D, Pegueroles J, Munoz L, Camacho V, Lopez-Mora D, Fernandez-Leon A, Le Bastard N, Huyck E, Nadal A, Olmedo V, Sampedro F, Montal V, Vilaplana E, Clarimon J, Blesa R, Fortea J, Lleo A. Agreement of amyloid PET and CSF biomarkers for Alzheimer's disease on Lumipulse. Ann Clin Transl Neurol. 2019 Sep;6(9):1815-1824. doi: 10.1002/acn3.50873. Epub 2019 Aug 28.

  PMID: 31464088 BACKGROUND

• Fowler CJ, Stoops E, Rainey-Smith SR, Vanmechelen E, Vanbrabant J, Dewit N, Mauroo K, Maruff P, Rowe CC, Fripp J, Li QX, Bourgeat P, Collins SJ, Martins RN, Masters CL, Doecke JD. Plasma p-tau181/Abeta1-42 ratio predicts Abeta-PET status and correlates with CSF-p-tau181/Abeta1-42 and future cognitive decline. Alzheimers Dement (Amst). 2022 Nov 25;14(1):e12375. doi: 10.1002/dad2.12375. eCollection 2022.

  PMID: 36447478 BACKGROUND

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MeSH Terms

Conditions

Alzheimer Disease; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 25, 2024
• Study Start: January 12, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 10, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

US (1)