Behavioral Interventions to Prevent or Delay Dementia

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 14-000885
    • Jacksonville, Florida: 14-000885
    • Rochester, Minnesota: 14-000885
    NCT ID: NCT02265757
    Sponsor Protocol Number: 14-000885

About this study

This study will compare the effectiveness of different combinations of 5 types of behavioral interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g. quality of life, cognition, function, mood) matter most to people at risk for dementia and their care partners. The results of this study have the potential to direct patients, families, and health care providers as to which combinations of behavioral interventions provide the greatest potential impact on which dementia prevention outcomes. Greater use of behavioral strategies that are targeted to the outcomes of most important to the patient will likely improve patient compliance and treatment adherence. This, in turn, can lessen the need for medication, health care, and long term care utilization.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • A candidate for the HABIT program with a diagnosis of amnestic MCI (confirmed at eligibility visit by a Clinical Dementia Rating (CDR) scale of 0.5).
  • A cognitively normal care partner who has at least twice-weekly contact with the participant.
  • Either not taking or stable on memory medicine(s) (e.g. donepezil) for at least 3 months.
  • Fluent in English. (Expanding the program to communities of Spanish- speakers will be a high priority in subsequent dissemination work).

Exclusion Criteria:

  • Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.
  • Medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Julie Fields, Ph.D., L.P.

Closed for enrollment

Contact information:

Teresa Radam CCRP

(480)342-3775

radam.teresa@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Julie Fields, Ph.D., L.P.

Closed for enrollment

Contact information:

Miranda Morris

(904)953-2677

Morris.Miranda@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Julie Fields, Ph.D., L.P.

Closed for enrollment

Contact information:

Sherrie Hanna M.A., L.P.

(507)538-8341

Hanna.Sherrie@mayo.edu