Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI)

Summary

The proposed study is designed to evaluate the performance of the ALTOIDA™ System as a tool to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings. The design of this study is guided by two overriding factors: 1) to optimize the performance of the ALTOIDA™ Neuro Motor Index (NMI) prognosis classifiers, the subjects making up the training sets must be well characterized as to their clinical diagnosis, and 2) all ALTOIDA™ tests must be performed and reproduced in real-world clinical settings.

Although there is already a large body of peer-reviewed scientific literature demonstrating that certain digital biomarker patterns are associated with certain neurologic conditions, the utilization of such tools for the evaluation of neurologic disorders is still considered an emerging science and therefore in the investigational stage. Although this protocol will report on brain patterns of certain neurologic conditions such as cognitive impairment and Alzheimer's disease, based on patterns published in peer-reviewed journals, such findings are not considered stand alone or diagnostic per se and should always be considered by the primary physician in conjunction with the patient's clinical condition. These data should only be used as additional information to add to the primary physician's diagnostic impression.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Memory Disorders
• Cognitive Impairment
• Dementia
• Presymptomatic Disease

Interventions

OTHER

Altoida: neuropsychological, MRI, EEG and CSF biomarkers

Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above. Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects.

Sponsors & Collaborators

• Greek Alzheimer's Association and Related Disorders

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• IRCCS Centro San Giovanni di Dio Fatebenefratelli

  collaborator OTHER

• Neuromed IRCCS

  collaborator OTHER

• Scripps Health

  collaborator OTHER

• Global Brain Health Institute (GBHI)

  collaborator OTHER

• Takeda Pharmaceuticals International, Inc.

  collaborator INDUSTRY

• Research Center on Computational BioMarkers

  collaborator OTHER

• Bioinformatics and Human Electrophysiology Laboratory

  collaborator OTHER

• Fundacion Clinic per a la Recerca Biomédica

  collaborator OTHER

• University of Dublin, Trinity College

  collaborator OTHER

• University of Barcelona

  collaborator OTHER

• EIT Health

  collaborator OTHER

• Klinik Hirslanden, Zurich

  collaborator OTHER

• The University of Texas at Dallas

  collaborator OTHER

• Altoida

  lead INDUSTRY

Principal Investigators

• Mark Wiederhold, PhD · Scripps Clinic La Jolla Poole Building

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-10-17

Primary Completion

2020-02-18

Completion

2020-02-21