A Randomized, Blinded, Controlled Trial of Music Therapy Singing Interventions for Patients With MCI and AD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Clinician's Global Impression of Change (ADCS-CGIC)
研究概览
简要总结
This study compares different music therapy (MT) experiences and their impact on memory and language in patients with Alzheimer's disease and Mild Cognitive Impairment.
The 12-month study will assess the role of common experiences involving familiar music and other pleasant events (blinded control) to benefit cognition and measure the quality of life for people with Alzheimer's disease and Mild Cognitive Impairment.
Following screening, all participants will meet with a licensed music therapist at the first study visit. Thereafter, each group will have an individualized schedule of follow-up telephone calls and visits.
Screening for the study and participation in the study intervention can be completed in-person or from your home, if you do not live in the area.
详细描述
Interested participants and their study partner will be enrolled after an evaluation to determine cognitive impairment or mild dementia. The evaluation, either in person or remote, will include cognitive testing, clinical and neurological evaluation, a review medical records and medical history and an examination as deemed necessary by a dementia physician. Eligible participants will undergo baseline testing including linguistic analyses and will be randomly assigned to one of 3 intervention groups. Participants and their study partners will be contacted at least once every three months for cognitive testing and medical review. Contact with the music therapy team will occur up to twice per week but not less than once per month, for the first six months study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
All treatment arms will be conducted at the Louis Armstrong Center for Music and Medicine with staff at that location while screening and all outcome evaluations will be conducted at the Alzheimer's Disease Research Center at the Mount Sinai location. A single unblinded team member at each site will coordinate visits and data collection.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Alzheimer's disease or mild cognitive impairment
- •Must have study partner
- •English speaking
- •No verbal impairment
- •Community-dwelling
- •Must have webcam or smart phone
排除标准
- •A diagnosis of dementia other than probable or possible AD
- •Probable AD with Down syndrome
- •History of a clinically significant stroke with residual deficit
- •Current evidence or history in past two years of epilepsy, focal brain lesion, head injury
- •Current diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
- •Participation in another interventional study
- •Comorbidity causing disability interfering with intervention such as pain or discomfort or life expectancy less than 1 year
结局指标
主要结局
Clinician's Global Impression of Change (ADCS-CGIC)
时间窗: 12 months
The Alzheimer's Disease Cooperative Study Clinician's Global Impression of Change. (ADCS-CGIC) to assess cognition, behavior and function. Full scale from 1-7, higher score indicates poorer health outcome.
Mini Mental Status Exam (MMSE)
时间窗: 12 months
Mini Mental Status Exam to assess cognition, behavior and function. Full score from 0-30, higher score indicates poorer health outcomes.
Neuropsychiatric Inventory (NPI)
时间窗: 12 months
Neuropsychiatric Inventory to assess cognition, behavior and function. The total NPI score is 0-144, higher score indicates poorer health outcomes.
Activities of Daily Living (ADCS-ADL)
时间窗: 12 months
The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) to assess cognition, behavior and function. The ADCS-ADL is a 23 item scale that includes 6 Basic ADL items and 17 Instrumental ADL items that provide a total score from 0-78, with a lower score indicating greater severity.
次要结局
- Zarit Burden Interview(12 months)
- The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)(12 months)
研究者
Mary C Sano
Director, Alzheimer's Disease Research Center
Icahn School of Medicine at Mount Sinai