Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Last updated: March 24, 2023
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Dementia

Treatment

Tailored Active intervention

Inactive intervention

Clinical Study ID

NCT01816152
7R01AG034157-11
  • Ages > 60
  • All Genders

Study Summary

Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • mild to moderate Alzheimer's disease and related dementia (ADRD) based on National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria,
  • Clinical Dementia Rating (CDR) of 1 to 2,
  • Mini-Mental State Examination (MMSE) between 8 and 24

Exclusion

Exclusion Criteria:

  • major organ failure,
  • major illness,
  • history of head injury,
  • hypertension or diabetes,
  • use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: Tailored Active intervention
Phase:
Study Start date:
January 01, 2020
Estimated Completion Date:
December 31, 2025

Study Description

In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    Troy, New York 12180
    United States

    Active - Recruiting

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