EUCTR2004-001336-22-SE进行中（未招募）不适用
Effect of Phenserine Treatment on Amyloid in Brains of Patients with Mild Probable Alzheimer’s Disease as studied by Positron Emission Tomography (PET).A Randomised, three Months Double-Blind, Placebo-Controlled Pilot Study followed by a three Months Open-Label Treatment with Phenserine or Aricept.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Axonyx Inc.
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
- •Inclusion criteria
- •Signed informed consent by patient or the legally accepted representative
- •prior to the initiation of any study specific procedures
- •Male or female patients of at least 50 years of age
- •Probable Alzheimer’s Disease consistent with NINCDS-ADRDA criteria
- •MRI or CT scan within the last 12 months prior to baseline shoud exclude
- •other aetiologies than AD to the patients dementia symptoms (e.g
- •Mini-Mental state examination score (MMSE) between 20 and 26 inclusive
- •Modified Hachinsky ischemic score equal or below 4
- •Female patients must be at least 2 years post-menopausal or surgically
- •Caregiver available, if not living in the same household, caregiver sees
- •patient at least 4 times a week
- •Patients living at home, old people’s home or an institutional setting
- •without continuous nursing care
- •General health status acceptable for a participation in a 6 month clinical
- •Subjects to be selected for participating in the study must undergo PET
- •studies with [18F]-fluorodeoxy-glucose (FDG) as a part of the screening
- •and show changes in cerebral metabolism consistent with AD
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Violation of inclusion criteria not approved by clinical study director or
- •study safety officer
- •Failure to perform or to evaluate screening or baseline examinations
- •Hospitalisation (except for study purposes or due to social reasons, e.g.
- •hospitalisation to unburden the caregiver) or change of concomitant
- •medication 4 weeks prior to screening or during screening period
- •Participation in another therapeutic clinical trial 3 months before baseline
- •Inability to swallow tablets
- •Unsubstituted vitamin B12 or folate deficiency
- •Serum electrolytes (sodium, potassium, magnesium) out of normal range
- •Unsubstituted hypothyroidism with TSH >6,00 µU/ml
- •Juvenile onset diabetes mellitus
- •Adult onset diabetes mellitus insufficiently controlled (HbA1c >8 %)
- •Renal insufficiency with serum creatinine >2 mg/dl
- •Severe hypotension requiring treatment with more than 2 drugs
- •Lab values seriously abnormal, and/or more than 2 lab values abnormal
- •not approved by clinical study director or study safety officer
- •Hypersensitivity to cholinergic drugs
- •Serious drug allergies
- •Malignant tumours within the last 5 years
- •Cardiovascular
- •Myocardial infarction or unstable angina within the last 6 months before
- •History of more than 1 myocardial infarction during the last 5 years
- •Cardiomyopathy
- •Myocarditis
- •Atrial fibrillation
- •Severe hypotension requiring treatment with more than 2 drugs
- •Severe hypertension requiring treatment with more than 2 drugs
- •Bradycardia (frequency of heart beat <50/min.)
- •Tachycardia (frequency of heart beat >90/min.)
- •Presence of AV block (type II / Mobitz II and type III)
- •Congenital long QT syndrome
- •Sinus node dysfunction
- •Prolonged QTcB-interval (males >450 and females >470 msec)
- •QTcB dispersion >100 msec
- •Presence of U wave
- •Psychiatric
- •Episode of major depression in medical history*)
- •History or presence of schizophrenia
- •Chronic intoxication or chronic substance use disorder with
- •pharmaceuticals, drugs, alcohol or industrial poisons
- •*) A major depression has to be excluded by the investigator. This will be done by appropriate scales or methods, if considered necessary, and documented in source data.
- •Neurological
- •Stroke within 6 months before screening or concomitant with onset of
- •Tumours, subdural haematoma or other space occupying processes on
- •Head trauma with loss of consciousness within 1 year before or concurrent
- •with onset of dementia
- •Onset of dementia within 1 year following cardiac arrest, surgery with
- •general anaesthesia or resuscitation
- 另有 15 项未显示
研究者
相似试验
招募中
不适用
Clinical Implementation of Amyloid Neurodegeneration and Tau testing in Primary Care.Alzheimer's diseaseNL-OMON56307Vrije Universiteit Medisch Centrum400
尚未招募
不适用
Post-stroke cognitive trajectory according to amyloid depositioDiseases of the nervous systemKCT0005086The Catholic University of Korea, Eunpyeong St. Mary's Hospital196
进行中（未招募）
不适用
The effects of Ritalin treatment on decision making and learning, and on brain activation, in adult ADHDAttention deficit hyperactivty disorderMedDRA version: 15.1Level: PTClassification code 10003736Term: Attention deficit/hyperactivity disorderSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2012-005246-38-NOniversity of Oslo
招募中
4 期
Effects of safinamide mesylate on neuroplasticity in patients with Parkinson's diseaseParkinson's diseaseJPRN-jRCTs061220070Hanajima Ritsuko30
已完成
不适用
Effect of methylphenidate on neural mechanisms underlying attention deficit after closed head injuryAttention deficit after closed head injuryMental and Behavioural DisordersIntracranial injuryISRCTN27103516Department of Health (UK)20