EUCTR2005-005765-11-EE进行中（未招募）不适用
Randomised, double-blind, placebo-controlled, parallel group trial to confirm the efficacy, safety and tolerability of Ginkgo biloba Special Extract EGb 761® in patients suffering from Mild Mental Impairment (MMI) - NA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •Patients are eligible for inclusion in this study, if they fulfil all of the following criteria:
- •1. Male or female outpatients aged 45 to 65 years (both inclusive)
- •2. Suffering from mild mental impairment as defined by the diagnostic criteria outlined under section 8.7 in clinical trial protocol:
- •a)subjective complaints of impairment – perceived as a decline from former level of functioning – in at least one of the following cognitive functions: memory, attention/concentration, speed of functioning, efforts required to complete complex tasks, general performance/efficiency
- •b)presence of at least one of the following neuropsychiatric symptoms: depressed mood/dysphoria, anxiety, irritability/lability, apathy/indifference, fatigue, decreased general wellbeing
- •c)perceived impairment present for at least 3 months
- •d)widely preserved general cognitive functioning, as evidenced by a total score above 23 in the MMSE
- •e)intact activities of daily living, as evidenced by inquiry (subtle difficulties, in particular slowing or increased efforts, in complex tasks is acceptable)
- •f)no indication of dementia
- •3. Written informed consent according to applicable law
- •4. Sufficient estonian language skills to understand and respond to all interview questions and undergo neuropsychological testing without evident difficulties and without the assistance of an interpreter
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with any of the following characteristics must not be included in the study:
- •1. Participation in another experimental drug trial at the same time or within the past 4 weeks before enrolment
- •2. Prior participation in a clinical trial with Ginkgo biloba within the last 3 months
- •3. Hospitalization of the patient
- •4. Ischaemic stroke with sequelae within the last 3 months
- •5. Cognitive impairment due to systemic or cerebral infection, somatic disorders, neurological disorders (e.g. dementia of any type, alcohol-associated brain damage, HIV-associated cognitive disorder, Parkinson’s disease, Huntington’s disease, Pick’s disease, Wilson’s disease, normal pressure hydrocephalus, progressive supranuclear palsy, Creutzfeldt-Jakob disease, brain tumour, subdural haematoma, multiple sclerosis, seizure disorder, brain trauma, etc) or psychiatric disorder (e.g. affective or anxiety disorder on a syndromal level), including clinical suspicion of any of the above.
- •6. History of recurrent major depression or recurrent anxiety disorder. If a single episode of such a disorder was present before, it must have been finished at least one year before enrolment.
- •7. D-S’ item score for item 11 (suicidal ideation) > 0
- •8. History of head trauma that might be causally related to cognitive impairment because of:
- •- its clinical severity or
- •- trauma-related lesions in CT or
- •- temporal relationship to the onset of cognitive dysfunction or
- •- repeated minor head trauma
- •9. Any use of antidementia drugs, nootropics, cognition enhancing drugs, CNS stimulants, cholinergic and anticholinergic drugs unless there is an at least 8-week washout before entering the randomised treatment period (for details see Section 6 in clinical trial protocol)
- •10. Any continued use of psychoactive drugs, such as antidepressants, neuroleptics, tranquilizers, sedatives, hypnotics, sedating anti-histamine agents, sedating analgesic drugs.
- •Occasional use (up to three times a week) of tranquilizers for sleep disturbances is permissible, but not within 48 hours prior to test sessions (for details see Section 6 in clinical trial protocol)
- •11. Any use of haemorrheologic drugs, anti-epileptics and anti Parkinson drugs unless there is a washout of at least 8 weeks before entering the randomised treatment period (for details see Section 6 in clinical trial protocol)
- •12. Substance addiction or abuse within the last 5 years
- •13. Severe, uncontrolled cardiovascular disease, especially:
- •-severe (stage IV acc. to Canadian Cardiovascular Society) or unstable angina pectoris
- •-decompensated congestive heart failure (NYHA stage IV)
- •-myocardial infarction within the last 6 months
- •-uncontrolled hypertension (systolic pressure > 180mmHg, diastolic pressure > 115mmHg)
- •-known clinically significant cardiac arrhythmias (Lown classes IVb and V)
- •14. Severe renal or hepatic dysfunction (serum creatinine or serum ASAT, ALAT or Gamma-GT above 3 times the upper limit of the reference range)
- •15. Insufficiently controlled insulin-dependent diabetes mellitus
- •16. Clinically significant anaemia
- •17. Known clinically significant thyroid dysfunction
- •18. Known HIV infection or Lues of any stage (according to medical history or clinical signs and symptoms)
- •19. Active malignant disease (Exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy)
- •20. Known hypersensitivity to Ginkgo biloba extract
- •21. Severe and insuf
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapsesMultiple sclerosisMedDRA version: 12.0Level: PTClassification code 10028245Term: <Manually entered code. Term in E.1.1>EUCTR2004-000555-42-DKSanofi-aventis US, Inc1,080
进行中（未招募）
1 期
To evaluate the efficacy and safety of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer's Disease (AD)MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Alzheimer's diseaseEUCTR2016-002976-28-ITOVARTIS PHARMA AG1,144
进行中（未招募）
1 期
Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173Primary Sjögren's syndromeMedDRA version: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2014-004616-12-DEovartis Pharma Services AG30
进行中（未招募）
1 期
Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney diseaseType II Diabetes Mellitus and Diabetic Kidney DiseaseMedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2015-000950-39-ITBAYER AG12,800
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-weektreatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 and 10mg/day as an aid to smoking cessation in cigarette smokers - SURSMOKEAid to smoking cessation in cigarette smokersMedDRA version: 8.1Level: LLTClassification code 10057852Term: Nicotine dependenceEUCTR2006-005334-21-DEsanofi-aventis recherche et developpement805