A Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy of a Non-Pharmacological Intervention of Cognitive Stimulation in Subjects With Alzheimer's Disease and Mild Cognitive Impairment: The Brain Stimulation Project.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change in global cognition as assessed by Mini Mental State Examination
研究概览
简要总结
The present study aims to evaluate the effect of cognitive stimulation (CS) in participants with a diagnosis of moderate and mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) compared to control subjects not receiving any non-pharmacological interventions. Treated participants will receive a structured CS consisting of a wide range of activities aimed at the general improvement of social functioning and the maintenance of cognitive functions. The study consists of a 24-week treatment phase and a follow-up period of 24 weeks. During the treatment period, patients will receive two CS sessions a week. At baseline, all the participants undergo an extensive neuropsychological evaluation and a neurophysiological assessment aimed at studying the frequency of spontaneous blinking (blink rate) and cortical excitability and synaptic plasticity by means of the transcranial magnetic stimulation (TMS). Neuropsychological and neurophysiological evaluations will be repeated at the end of the treatment (week 24) and at the end of the follow-up period (week 48) in order to evaluate short- and long-term effects of CS. The hypothesis of this research is that CS may improve cognition and the neurophysiological parameters studied in treated participants compared to those untreated.
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
- Single (Outcomes Assessor)
盲法说明
Single Blind: Neuropsychologists and Neurophysiologists are prevented from having knowledge of the intervention assigned to the participants.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate AD participants
- •Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- •1 < Clinical Dementia Rating Scale < 3
- •13 ≤ Mini-Mental State Examination < 20/30
- •Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
- •Geriatric Depression Scale (GDS) ≤ 6
- •mild AD participants
- •Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- •Clinical Dementia Rating Scale = 1 (memory box score ≥ 0.5)
- •20 > Mini-Mental State Examination < 27/30
- •Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
- •Geriatric Depression Scale (GDS) ≤ 6
- •MCI participants
- •Clinical diagnosis of probable AD (National Institute on Aging and Alzheimer's Association criteria)
- •Clinical Dementia Rating Scale < 1 (memory box score ≥ 0.5)
- •Mini-Mental State Examination ≥ 24/30
- •Modified Hachinski Ischaemic Scale (MHIS) ≤ 4
- •Geriatric Depression Scale (GDS) ≤ 6
排除标准
- •for all the participants (moderate AD, mild AD and MCI):
- •Any medical or neurological condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment.
- •Clinically significant psychiatric illness (e.g., uncontrolled major depression, bipolar affective disorder) within 6 months prior to the enrolment.
- •Any medications that, in the opinion of the Investigator, may contribute to cognitive impairment or impair the subject's ability to perform cognitive testing or complete study procedures.
- •Contraindications to Transcranial Magnetic Stimulation (history of epilepsy or seizures/presence of pacemaker).
- •Subject currently living in an organized care facility with extensive intervention and/or support of daily living activities.
- •Inability to comply with study requirements and commitments
- •Has not one informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the subject as to be able to provide accurate information about the subject's cognitive and functional abilities.
研究组 & 干预措施
moderate AD-experimental
Experimental Intervention: The CS shall be carried out in groups (5-7 participants), twice a week. Each session lasts 90 minutes. CS sessions begin with a training for temporal and spatial orientation in which participants are asked to recognize and recall the date and the place with the help of some environmental aids (calendars, clocks, pictures and maps). Then the participants complete an array of cognitive tasks for memory, attention, language, visuo-spatial functions and executive functions. These tasks range from individual paper-and-pencil exercises to verbal-learning exercises that have to be solved by the group.
干预措施: Cognitive Stimulation (CS) (Other)
mild AD-experimental
Experimental Intervention: the same of the "moderate AD-experimental" arm
干预措施: Cognitive Stimulation (CS) (Other)
MCI-experimental
Experimental Intervention: the same of the "moderate AD-experimental" arm
干预措施: Cognitive Stimulation (CS) (Other)
moderate AD-placebo
mild AD-placebo
MCI-placebo
结局指标
主要结局
Change in global cognition as assessed by Mini Mental State Examination
时间窗: 24 and 48 weeks
Change from baseline in Mini Mental State Examination score at Week 24 and 48. This scale investigates global cognition. Scale range: 0-30. Normal values \>24. Higher values represent a better outcome.
Change in dementia severity as assessed by Clinical Dementia Rating Scale
时间窗: 24 and 48 weeks
Change from baseline in Clinical Dementia Rating Scale score at Week 24 and 48. This scale investigates global cognition and dementia severity. Scale range: 0-5. Normal values = 0. Higher values represent a worse outcome.
次要结局
- Change in frontal functions as assessed by Frontal Assessment Battery(24 and 48 weeks)
- Change in verbal memory as assessed by Rey Auditory Verbal Learning Test(24 and 48 weeks)
- Change in attention as assessed by Visual Search Test(24 and 48 weeks)
- Change in visuospatial functions as assessed by Clock Drawing Test(24 and 48 weeks)
- Change in naming as assessed by Boston Naming Test(24 and 48 weeks)
- Change in synaptic plasticity as assessed by Paired Associative Stimulation(24 and 48 weeks)
- Change in blinking as assessed by Blink Rate Evaluation(24 and 48 weeks)
研究者
Carlo de Lena
Department of Human Neuroscience
University of Roma La Sapienza