NCT05596994Befejeződött
7T MRI for Light Therapy in Patients With Mild Cognitive Impairment and Mild AD
Use of 7T Multimodal Imaging to Detect Brain Changes Associated With Light Therapy in Persons With Mild Cognitive Impairment and Mild Alzheimer's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 29.
Rövid összefoglaló (regiszter, angolul)
The purpose of this research study is to investigate the effect of a light treatment on sleep, memory and brain function. In people with mild cognitive impairment (MCI) and Alzheimer's disease, sleep-wake disturbance is evident in up to 60% of patients. This can be caused by disruption of circadian rhythms and may affect our health and well-being. Circadian rhythms are the natural cycle of physical, mental, and behavior changes that the body goes through in a 24-hour cycle. Circadian rhythms are mostly affected by light and darkness and are controlled by a small area in the middle of the brain. They can affect sleep, body temperature, hormones, appetite, and other body functions. The circadian system plays an important role in the body and can affect sleep and brain function. The results of the research would help develop light-delivery methods to improve sleep and memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease who typically spend a significant amount of time indoors.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 24 (tényleges)
- Első benyújtás
- 2022. okt. 25.
- Kezdés
- 2023. febr. 28.
- Elsődleges befejezés
- 2025. máj. 30.
- Fő szponzor
- Icahn School of Medicine at Mount Sinai
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT05596994
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 24
- 2023. febr. 28. és az elsődleges befejezés (2025. máj. 30.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Those taking sleep medication will be not included
- obstructing cataracts, macular degeneration, and blindness
- o Those who have undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm) will also be excluded
- 7T MRI specific exclusions including presence of metallic or biomedical implants (patients can be enrolled at the discretion of the study team and site MRI technicians) and claustrophobia
Más betegség
- Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- indication for psychiatric hospitalization or acute suicidality in the opinion of the physician
- major organ failure (e.g., kidney failure)
- uncontrolled generalized disorders such as hypertension or diabetes
- severe sleep apnea:
- o Apnea will be screened for using the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ), a 12-item scale yielding scores between 0 and 60.3. The study will use a score of 29 as a cutoff for men (sensitivity 75%, specificity 65% for sleep apnea), and a cutoff of 26 for women (sensitivity 80%, specificity 67%).
- restless leg syndrome (RLS):
- o RLS will be screened for using the International Restless Legs Scale (IRLS), a 10-item scale that yields scores between 0 and 40.4 The study will use a cutoff of greater than or equal to 11 (indicating the presence of symptoms that are at least moderate) as a positive screen for RLS
- history of:
- severe photosensitivity dermatitis
- severe progressive retinal disease (e.g., macular degeneration), or;
- a permanently dilated pupil (e.g., after certain types of cataract surgery)
Egyéb
- residence in a skilled nursing facility or long-term care
- recent changes in psychotropics (14 days)
Kiket keres a vizsgálat
- the patients must have undergone PET scans to measure amyloid protein accumulation within the past year
- Those taking antidepressants will be included, but type of medicine and dosage intake will be monitored.
- 50 years and older
- Eligible participants will be amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) patients with circadian sleep disturbances who reside in their homes, independent living, or assisted living facilities.
- confirmed amyloid beta positive from an existing ADRC cohort with PET scan (age: 50-85 yrs, 40% M, 60% F; falling between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB)
Életkor a regiszterben: 50 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | New York | Egyesült Államok | Ismeretlen állapot |
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