Effects of Endogenous and Exogenous Risk Factors in Patients With Alzheimer's and Parkinson's Diseases Using Clinical Indexes and Endophenotypes (Biomarkers) as Inputs to Artificial Intelligence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Predictivity in changes of RMN parameters
研究概览
简要总结
Investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in the CSF, brain connectivity, and some clinical and biological indices such as vigilance, general motility, the sleep-wake cycle, genomic instability and possible DNA damage may correlate with (or predict) the clinical condition of mild cognitive impairment (MCI) and dementia in patients with Alzheimer's disease (AD) and Parkinson's disease (PD).
详细描述
Study Description
Brief Summary
The study will investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in cerebrospinal fluid (CSF), brain connectivity, and selected clinical and biological indices, including vigilance, general motility, sleep-wake cycle characteristics, genomic instability, and DNA damage, are associated with or predictive of mild cognitive impairment (MCI) and dementia in patients with Alzheimer's disease (AD) and Parkinson's disease (PD).
Detailed Description
Parkinson's disease (PD) and Alzheimer's disease (AD) are characterized by progressive neurodegeneration associated predominantly with alpha-synuclein and beta-amyloid pathology, respectively. In patients with PD, mild cognitive impairment (PD-MCI), characterized primarily by executive dysfunction, and Parkinson's disease dementia (PDD) are common and have been associated with functional abnormalities in frontal, temporal, and parietal neural networks as identified through resting-state electroencephalography (rsEEG) and magnetic resonance imaging (MRI). In patients with AD-related MCI (AD-MCI) and Alzheimer's disease dementia (ADD), these techniques have revealed predominant episodic memory deficits associated with alterations in default mode and visuospatial neural networks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be over 60 years of age;
- •The Subject must have a full understanding of the Italian language;
- •The subject is available to participate in the phase telemonitoring.
排除标准
- •Inability to sign the informed consent;
- •Severe dementia;
- •Other concomitant diseases;
- •Inability to participate in study procedures;
- •Presence of arrhythmia, heart failure or previous heart attack, peripheral vascular disease or impaired circulation, valvular disease (diseases affecting the aortic valve), other diseases known conditions, end-stage renal disease (ESRD), diabetes, neurological disorders (e.g example, tremors), bleeding disorder or taking prescribed anticoagulants, tattoo(s) on the wrist where you will wear the Samsung Galaxy Watch, you will have an implanted pacemaker, a defibrillator implanted heart or other implanted electronic devices.
研究组 & 干预措施
Alzheimer MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: EEG (Other)
Alzheimer MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Neuropsycological assesment (Diagnostic Test)
Alzheimer MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: cerebral MRI (Radiation)
Alzheimer MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Venous blood sample of 20ml (Biological)
Alzheimer MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Sample collection of exfoliated buccal mucosa (Biological)
Alzheimer MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Telemonitoring at home for 1 week (Device)
healthy subjects
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa.
干预措施: Neuropsycological assesment (Diagnostic Test)
healthy subjects
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa.
干预措施: cerebral MRI (Radiation)
healthy subjects
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa.
干预措施: EEG (Other)
healthy subjects
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa.
干预措施: Venous blood sample of 20ml (Biological)
healthy subjects
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa.
干预措施: Sample collection of exfoliated buccal mucosa (Biological)
Alzheimer Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Neuropsycological assesment (Diagnostic Test)
Alzheimer Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: cerebral MRI (Radiation)
Alzheimer Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: EEG (Other)
Alzheimer Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Venous blood sample of 20ml (Biological)
Alzheimer Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Sample collection of exfoliated buccal mucosa (Biological)
Alzheimer Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Telemonitoring at home for 1 week (Device)
Parkinson Disease MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Neuropsycological assesment (Diagnostic Test)
Parkinson Disease MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: cerebral MRI (Radiation)
Parkinson Disease MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: EEG (Other)
Parkinson Disease MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Venous blood sample of 20ml (Biological)
Parkinson Disease MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Sample collection of exfoliated buccal mucosa (Biological)
Parkinson Disease MCI
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Telemonitoring at home for 1 week (Device)
Parkinson Disease Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Neuropsycological assesment (Diagnostic Test)
Parkinson Disease Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: cerebral MRI (Radiation)
Parkinson Disease Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: EEG (Other)
Parkinson Disease Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Venous blood sample of 20ml (Biological)
Parkinson Disease Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Sample collection of exfoliated buccal mucosa (Biological)
Parkinson Disease Dementia
- Neurological examination and collection of anamnestic information;
- Collection of the instrumental data;
- Neuropsychological Assesment;
- Venous blood sample of 20ml;
- Sample collection of exfoliated buccal mucosa;
- Training of the correct use of home telemonitoring devices;
- Telemonitoring at home for 1 week.
干预措施: Telemonitoring at home for 1 week (Device)
结局指标
主要结局
Predictivity in changes of RMN parameters
时间窗: At patient's enrollment (Baseline)
Changes in MRI-derived measures assess brain structural integrity, including white matter damage and the preservation of cortical networks. In detail, the following parameters will be measured: White matter lesions MRI cortical network volumes Default Mode Network (DMN) Dorsal Attention Network (DAN)
Predictivity of EEG
时间窗: At patient's enrollment (baseline)
Predictivity of changes in spectral power, measured using rsEEG sources, in detail: Power spectral density Delta band Theta band Alpha 1 band Alpha 2 band Beta 1 band Beta 2 band Gamma band
Predictivity of CFS and Blood derived Biomarkers
时间窗: At patient's enrollment (Baseline)
Measurement of Biomarkers in CFS and Blood samples. In particular, from CSF we will evaluate the following biomarkers: t-tau p-tau Aβ (Amyloid-beta) in blood samples we will evaluate: N-oxoaspartic acid N-acetylspermidine Methylselenopyruvate N-methylethanolamine phosphate Succinylacetone Capryloylglycine Acetylhistamine Androsterone Glutaric acid Cadaverine Quinolinic acid Maleylacetic acid N-methyladenosine D-erythrose L-cysteine Dethiobiotin Tetradecenoylcarnitine Beta-hydroxybutyric acid L-pyroglutamic acid Creatine Uric acid Propionylcarnitine Ophthalmic acid Homovanillic acid L-histidine L-serine phosphate Nicotinuric acid Diaminoadenosine L-methionine L-asparagine
Predictivity of clinical parameters
时间窗: At patient's enrollment (Baseline)
The following clinical assessment tools will be used: Clinical assessment scales MDS-UPDRS Part III Beck Depression Inventory-II (BDI-II) Mini-Mental State Examination (MMSE) Montreal Cognitive Assessment (MoCA) Rey Auditory Verbal Learning Test - Immediate Recall (RAVLT Immediate) Rey Auditory Verbal Learning Test - Delayed Recall (RAVLT Delayed) Clock Drawing Test Semantic Fluency Test Phonemic Fluency Test Clinical and lifestyle variables Heart rate Physical activity Smoking status Hypertension Comorbidities (any additional disease) Body Mass Index (BMI)
Predictivity of digital telemonitoring
时间窗: From enrollment to the end of telemonitoring at day 7
By using electronic devices such as tablets and smartwatch we will assess parameters of cognitive function and quality of sleep. In details, by using specifically designed video games we will measured reaction time and accuracy of reaction. Quality of sleep will be recorded by wearing a smartwatch that will measure sleep duration, efficiency and quality. Interactive serious videogame response assessment Accuracy Reaction time Watch-derived measures Sleep duration Sleep efficiency Sleep quality Steps per day Intentional steps Incidental steps Average cadence during the best 30 minutes of the day
次要结局
未报告次要终点