EUCTR2015-003188-13-IT进行中（未招募）1 期
Pilot study on the association choline alphoscerate-nimodipine in patients with subcortical vascular cognitive impairment - CONIVAD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Cognitive impairment from mild to moderate degree defined by a Clinical Deterioration Rating (CDR) score range between 0.5 and 2.0.
- •2) Evidence on brain MRI of white matter hyperintensities (leukoaraiosis of moderate or severe degree according to the modified Fazekas visual scale and/or presence of lacunar infarcts).
- •3) Consent to participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1) Absence of objectivizable cognitive impairment or presence of dementia of severe degree defined by CDR score > 2.0.
- •2) Unavailability of brain MRI (in case of absolute contraindications, the use of cranial CT is allowed).
- •3) Expected poor compliance with the study protocol.
- •4) Past diagnosis of major depression,
- •schizophrenia, major anxiety syndrome, or manic- depressive illness.
- •5) Diagnosis of degenerative cognitive impairment based on clinical and/or neuroradiological findings (i.e., patients with prevailing memory impairment, or with medial temporal atrophy on brain MRI in absence of evident vascular abnormalities; i.e., Alzheimer disease as defined using the NINCDS/ADRDA criteria, Parkinson disease, Huntington disease, frontotemporal dementia).
- •6) Diagnosis of cognitive impairment from other causes (i.e., vitamine B12 and folic acid deficiency, thyroid disorders, metabolic diseases, head trauma, tumor or infections of the central nervous system, normal pressure hydrocephalus).
- •7) Medical conditions expected to progress, recur, or change to such a degree to interfere with the assessment of the clinical and mental status.
- •8) Clinically relevant cardiac or pulmonary insufficiency.
- •9) Relevant electrocardiograph abnormalities; bradycardia (50 bpm) or tachycardia (120 bpm) under resting conditions.
- •10) Myocardial infarction within the past 6 months.
- •11) Stroke still requiring neurological rehabilitation.
- •12) Severe/untreated blood pressure (systolic 180 mm Hg, diastolic 95 mm Hg).
- •13) Clinically relevant liver function impairment.
- •14) Insulin-dependent diabetes mellitus.
- •15) Idiopathic epilepsy and anti-epileptic treatment.
- •16) Severe anemia (Hb <10 mg/dL).
- •17) Severe gastrointestinal disease.
- •18) Cancer.
- •19) Known intolerance to study drugs.
- •20) Coexistent serious illnesses that would imply a drop-out before the end of the trial.
研究者
相似试验
已完成
2 期
Choline Alphoscerate-Nimodipine in Vascular Cognitive ImpairmentVascular Cognitive ImpairmentNCT03228498Azienda Ospedaliero-Universitaria Careggi62
进行中（未招募）
1 期
.a.EUCTR2021-003437-10-ITAzienda Socio Sanitaria Territoriale di Lodi20
尚未招募
不适用
Evaluation of clinical effectiveness of choline alphoscerate for older adults with major depressioMental and behavioural disordersKCT0007062Samsung Medical Center120
Unknown
4 期
A Clinical Trial for an Evaluation of Choline Alfoscerate and Donepezil for Cognitive Improvements of Patients With Cerebrovascular Injury in Alzheimer PatientsAlzheimer DiseaseNCT02648906Daewoong Pharmaceutical Co. LTD.128
招募中
不适用
Effect on the cognitive function of Choline Alfoscerate in combination with donepezilKCT0004660Seoul National University Hospital200