Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

Официальное название

Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease

Обзор

Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light \[RL\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.

Подробное описание

The tailored lighting intervention used to promote circadian entrainment will provide high circadian stimulation during the day produced by narrowband blue light peaking at 470 nanometers (nm). A comparison lighting intervention (i.e., placebo lighting), a narrowband red light peaking at 630 nm, will be used as a control. Both the red and the blue light devices will also provide either the 40 hertz (Hz) flicker (RL) or the random flicker (placebo RL). For the random flicker (placebo RL), the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz).

Вмешательства

• Устройство Circadian-Effective Light
  Narrowband blue light
• Устройство Rhythmic Light
  40 hertz (Hz) flicker
• Устройство Placebo Light
  Narrowband red light
• Устройство Placebo Rhythmic Light
  Random flicker for placebo rhythmic effect

Первичные конечные точки

• Cognition using the Montreal Cognitive Assessment (MoCA) [Срок оценки: baseline]
• Cognition using the Montreal Cognitive Assessment (MoCA) [Срок оценки: at the end of week 9]
• Cognition using the Montreal Cognitive Assessment (MoCA) [Срок оценки: at the end of week 14]

Вторичные конечные точки (12)

• Cognition using a working memory task [Срок оценки: baseline]
• Cognition using a working memory task [Срок оценки: at the end of week 9]
• Cognition using a working memory task [Срок оценки: at the end of week 14]
• Cognition using a word pair associates task [Срок оценки: baseline]
• Cognition using a word pair associates task [Срок оценки: at the end of week 9]
• Cognition using a word pair associates task [Срок оценки: at the end of week 14.]
• Cognition using an implicit priming task [Срок оценки: baseline]
• Cognition using an implicit priming task [Срок оценки: at the end of week 9]
• Cognition using an implicit priming task [Срок оценки: at the end of week 14.]
• Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale [Срок оценки: baseline]
• Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale [Срок оценки: at the end of week 9]
• Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale [Срок оценки: at the end of week 14.]

Критерии участия

Критерии включения

• Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;
• Have sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index
• Participants must reside in their homes, independent living, or assisted living facilities

Критерии исключения

• Participants taking sleep medication
• Residence in a skilled nursing facility or long-term care
• Obstructing cataracts, macular degeneration, and blindness
• Severe sleep apnea or restless leg syndrome
• History of severe epilepsy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Light and Health Research Center — Menands
• Icahn School of Medicine at Mount Sinai — New York

Публикации

• Rea MS, Figueiro MG, Bullough JD, Bierman A. A model of phototransduction by the human circadian system. Brain Res Brain Res Rev. 2005 Dec 15;50(2):213-28. doi: 10.1016/j.brainresrev.2005.07.002. Epub 2005 Oct 7. PMID 16216333
• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. PMID 15817019
• Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356. PMID 6496779
• Figueiro MG, Hamner R, Bierman A, Rea MS. Comparisons of three practical field devices used to measure personal light exposures and activity levels. Light Res Technol. 2013 Aug;45(4):421-434. doi: 10.1177/1477153512450453. PMID 24443644
• Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. PMID 1947597
• Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982 Jun;140:566-72. doi: 10.1192/bjp.140.6.566. PMID 7104545
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID 2748771
• McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939. PMID 6610841

Идентификаторы

NCT: NCT05016219 · GCO 21-0378-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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