Alzheimer Hastalığında Beyin İşlevlerini İyileştirmek İçin Günlük Işık ve Ses Uyarımı

Sade dilde özet

Bu çalışma, Alzheimer hastalığında (Alzheimer's disease) beyin işlevlerini iyileştirmek amacıyla GENUS cihazı ile uygulanan günlük ışık ve ses uyarımını değerlendirmektedir. Hafif Alzheimer hastalığı olan ve 50-100 yaş arası bireyler katılabilmektedir. Çalışma faz uygulanmayan bir çalışma olarak yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Devam ediyor, katılım kapalı

Sponsor

Massachusetts Institute of Technology

Müdahale

GENUS device (Active Settings), GENUS device (Sham Settings)

Başlangıç

14.08.2019

Tahmini bitiş

15.01.2027

Ülkeler

United States

İlgili genler

Merkezler

• Cambridge, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Subject is between the ages of 50 - 100.
* Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26.
* Subject is willing to sign informed consent document.
* If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.
* Subjects whose primary residence is within 2 hours of Boston
* Able to complete the 1st month of at home stimulation at their primary residence; if subjects plan to spend more than 1 week away from their primary residence during the trial, their inclusion must be assessed by the research team.

Exclusion Criteria:

* Subjects who do not have healthcare.
* Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
* Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
* Subjects with history of seizure or epilepsy within the past 24 months.
* Subjects with clinically significant suicide risk and/or suicide attempt in the past 12 months.
* Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
* Active treatment with one or more anti-epileptic agent.
* Subjects who have had a stroke within the past 24 months.
* Subjects diagnosed with migraine headache.
* Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
* Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
* Subjects who have profound hearing or visual impairment.
* Subjects who have a life expectancy of less than 24 months.
* Subjects who are pregnant.