Electronic Validation of Online Methods to Predict and Monitor Cognitive Decline (e-VAL)

Overview

About this study

The goal of this project is to assess the validity and efficacy of online methods to predict and monitor cognitive and functional decline in elders with normal cognition (CN), subjective memory complaints (SMC), and mild cognitive impairment (MCI) using electronic versions of the Clinical Dementia Rating Scale (CDR) and the Financial Capacity Instrument-Short Form (FCI-SF). We will validate the e-instruments by implementing them within the Brain Health Registry (BHR, CHR #12-09628), and comparing online data obtained unsupervised at home with online data obtained while supervised in research clinics, over the telephone, or by video technology from participants followed longitudinally for 4 years and across 4 sites. In addition to the newly-developed electronic CDR (eCDR) and electronic FCI (eFCI), we will use BHR data, including the Cogstate Brief Battery and additional self-report questionnaires, to determine whether these electronic instruments can both measure and predict cognitive and functional decline. We also intend to determine the ability of electronic instruments to predict ß-amyloid (Aß) PET positivity. The development and validation of scalable, accessible screening tools, such as online electronic instruments, will likely lead to improved methods that can be used in clinical trials and multiple healthcare settings to identify people at risk for and undergoing cognitive and functional decline and Alzheimer’s disease (AD), ultimately leading to prevention of AD and improved healthcare for neurodegenerative disorders.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. 1. Participants will be eligible to participate provided they meet the following criteria:
    1. Adults age 55 years and older
    2. Fluent in English
    3. Able to give informed consent at baseline
    4. Access and the ability to use the internet
    5. Access to a computer either at home or wherever they have quiet, uninterrupted access to the internet
    6. Availability of an eligible study partner
  2. Study partners will be eligible to participate provided they meet the following criteria:
    1. Adults age 18 years and older
    2. Have regular and frequent interaction (in person or by telephone or online contact) with the participant
    3. Fluent in English
    4. Able to give informed consent
    5. Access and the ability to use the internet
    6. Access to a computer either at home or wherever they have quiet, uninterrupted access to the internet

Exclusion Criteria:

1. 1. Participants will be excluded from participation if any of the following are present:
    1. Unable to give consent and/or unable to consent online at baseline (determined by online screening questionnaire in the Brain Health Registry)
    2. Evidence or diagnosis of dementia – Clinical Dementia Rating (CDR) greater than 1 at baseline. Participants who transition to Dementia or become untestable while in the study will be asked to remain in the study and continue to be followed.
    3. Evidence of acute or uncontrolled medical illness
    4. Recent history (< 6 months) of abuse or dependence of drugs and/or alcohol
  2. Participants completing the supervised portion of the study, will be excluded for any of the following:
    1. Opinion of the Investigator that the participant is otherwise unsuitable for study
  3. Additionally, at the study sites that are already collecting the CDR, the study staff will gather reasons for why participants choose to decline or are excluded from completing the eCDR, as well as track the number of participants who complete the CDR but are excluded from this study. This information will be de-identified and shared with collaborators.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Ronald Petersen, M.D., Ph.D.	Closed for enrollment	Contact information: Alzheimer's Disease Research Center (507) 284-1324 -

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ronald Petersen, M.D., Ph.D.

Closed for enrollment

Contact information:

Alzheimer's Disease Research Center

(507) 284-1324

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More information

Publications

Publications are currently not available

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