NCT01425957已完成不适用
Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Two-part Clinical Study. PartA: Multisite MRI Acquisition, Protocol Harmonization. PartB: Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Qualissima
- 入组人数
- 229
- 试验地点
- 26
- 主要终点
- Part B: Changes of the hippocampal volume
研究概览
简要总结
THE STUDY WILL BE A TWO-PART RESEARCH
PART A and PART A extended:
- To implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners).
- Apply the common MRI protocol on phantoms and human subjects to characterize, compare and minimize test-retest variability across the MR sites of WP5 for all the quantitative metrics that will be later assessed on patients.
PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and neurophysiological data in Mild Cognitive Impairment patient, we aim to:
- To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) which is more sensitive than the changes observed in the loss of hippocampal volume (primary endpoint) and correlate with the neuropsychological progression and conversion (clinical secondary endpoints).
- To develop a biomarker MATRIX (made of a combination of biological secondary endpoints) at baseline which is more predictive of the loss of hippocampal volume (primary endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI patients.
- To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be (i) healthy volunteers (between 50 and 80 years old) and/or (ii) subjects (between 50 and 80 years old), who will perform a 3T-MRI for reasons such as migraine, headache, auditory or visual symptoms, paresthesias, and whose scan will be negative (see
排除标准
- •below). Such subjects will be selected and asked to perform additional sequences according to the part A study protocol.
- •Specific inclusion criteria:
- •Written Informed Consent to participate in a up to 3 year imaging study
- •Male and female aged between 55-90 years
- •Memory complaint by patient or partner that is verified by a physician. (Memory complains expressed by the patients or their informant that the examiner considers to be relevant and exceed those expected for a patient of their age. The patient may or may not have symptoms of deficiency in other cognitive areas.)
- •Abnormal memory functions documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale.
- •General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit.
- •Mini-Mental State Exam score between 24 and 30 (inclusive)
- •Clinical Dementia Rating = 0.
- •Memory Box score must be at least 0.
- •Amnestic Mild Cognitive Impairment (MCI) (pure amnestic or multidomain)
- •Geriatric Depression Scale less than 6
- •Hachinski Modified Ischemic scale< to 4
- •Patient is untreated or under a permitted medication (Cholinesterase inhibitors and memantine, before the enrolment and newly prescriptions during the study, are permitted for aMCI patients.)
- •At least 5 grades education
- •Must speak (language) fluently
- •Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
- •Willing and able to comply with the requirements of the study, as judged by the investigator
- •Exclusion Criteria:
- •Ischaemic lesions already detected in a previous scan
- •Head injury with loss of consciousness > 24 hours
- •Current substance abuse
- •Current therapy with steroids or current chemotherapy
- •Loss of weight > 5 kg in the last 6 months
- •Systemic disease with frequent involvement of the CNS (lupus, HIV, rheumatoid arthritis)
- •CNS disease diagnosed by a specialist or in treatment (such as epilepsy, ictus)
- •Cerebral metastasis or CNS primary tumour still benign (except for pituitary microadenoma)
- •Suspected multiple sclerosis + MRI evidence of white matter lesions
- •Suspected recent stroke + MRI evidence of infarct
- •Aneurysm > 10 mm and arteriovenous malformations (except for venous angioma)
- •Dysgenesia of central nervous system
- •Visual and auditory acuity inadequate for neuropsychological testing
- •Enrolment in other trials or studies not compatible with study objectives (in particular, those with experimental drugs)
- •History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment.
- •Use of forbidden medications
- •Ferromagnetic implants and devices not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
- •Excluded Medication: Antidepressants with anti-cholinergic properties and within 4 weeks of the screening: Regular use of narcotic analgesics (>2 doses per week), Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine), Chronic use of other medications with significant central nervous system anticholinergic activity (e.g., diphenhydramine), Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegiline), Participation in any other investigational drug study (individuals may not participate in any drug study while participating in this protocol). Diuretic drugs should not be started or discontinued within 4 weeks prior to screening (Any change in diuretic medication during the study should be reported).
结局指标
主要结局
Part B: Changes of the hippocampal volume
时间窗: 2 or 3 times: every 18 months during 2 or 3 years (T0, T18 and/or T36)
The primary endpoint will be changes of the hippocampal volume between the two groups (differentiated by the level of amyloid β1-42 in the cerebro-spinal fluid) and within the same group over time.
Part A: Magnetic Resonance Imagery protocol
时间窗: Two times: One measure at day 1
The Magnetic Resonance Imagery protocol comprises a localiser or scout run, 4 structural-volumetric MRI sequences (i.e. 2 MP-RAGE, 1 FLAIR and 1 T2\*), a resting state functional MRI acquisition (i.e. rsfMRI), a diffusion tensor scan (i.e. DTI) that will be conducted at the magnetic field strength of 3T and a quantitative assessment of brain perfusion changes with a sequence of Arterial Spin Labelling (i.e. ASL) . The field map will be used for geometric distortion correction of the fMRI data. The main parameter of "efficacy" will be the reliability of the acquired MRI data (in terms of their correct acquisition and limited variability).
次要结局
- Part B: Neurophysiology(Every 6 months (T0, T6, T12, T18, T24, T30 and T36))
- Part B: Blood drawing(Every 6 months)
- Part B: Clinical assessment(Every 6 months (screening, T6, T12, T18, T24, T30 and T36))
- Part B: Neuropsychology(Every 6 months (screening, T6, T12, T18, T24, T30 and T36))
- Part B: Actigraphy(Every 6 months (T0, T6, T12, T18, T24, T30 and T36))
- Part B: Magnetic Resonance Imagery and functional MRI(Every 6 months (screening, T0, T6, T12, T18, T24, T30 and T36))
- Adverse events(Every 6 months (T0, T6, T12, T18, T24, T30 and T36))
研究者
研究点 (26)
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