EUCTR2004-000933-12-ES进行中（未招募）不适用
A randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of phenserine-tartrate in patients with probable mild to moderate Alzheimer’s disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Axonyx Inc
- 入组人数
- 530
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
- •To be eligible for inclusion in this study, each patient must fulfil the following criteria:· Males of at least 50 years of age;
- •Females of at least 50 years of age, who are either at least 2 years post-menopausal or surgically sterile;
- •Probable Alzheimer’s disease consistent with National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria;
- •Have had a computed tomography (CT) or magnetic resonance imaging (MRI) brain scan within the 12 months prior to inclusion in the study that is indicative of probable Alzheimer’s disease;
- •A Mini-Mental State Examination (MMSE) score of between 12 and 24 (inclusive) at Visit 1 (screening);
- •A modified Hachinsky Ischemic Scale (mHIS) score equal to or below 4 at Visit 1 (screening);
- •Reliable caregiver available, and if not living in the same household, caregiver sees patient at least 4 times a week or a total of 15 to 20 hours per week;
- •Patients who do not need continuous nursing care and who are either living at home or in an institutional setting;
- •General health status acceptable for participation in a 6 month clinical study;
- •Is capable of understanding and has given written informed consent [or this has been provided by their acceptable representative (according to local requirements)] and a separate caregiver responsibilities and consent form has also been signed by the patient’s caregiver;
- •Agrees to comply with protocol requirements.
- •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
- •Patients are not eligible for inclusion in this study if they fulfil one or more of the following criteria: General·
- •Failure to perform or comply with screening or baseline examinations;
- •Hospitalisation (except for study purposes or due to social reasons, e.g. hospitalisation to unburden the caregiver);
- •Change of concomitant medication 4 weeks prior to screening or during screening period;
- •Participation in another therapeutic clinical study within the 3 months before Visit 2 (baseline);
- •Inability to swallow tablets.
- •Vitamin B12 or folate deficiency unless treated in which case treatment needs to have been stable for 3 months before study entry;
- •Hypothyroidism, defined as any thyroid-stimulating hormone elevation. Corrected hypothyroidism is allowed provided treatment has been stable for 3 months before study entry;
- •Juvenile onset diabetes mellitus;
- •Adult onset diabetes mellitus insufficiently controlled [Haemoglobin A1c (HbA1c) > 8%];
- •A malignancy within the last 5 years;
- •HIV infection;
- •Any history of hepatic insufficiency or abnormal liver enzymes;
- •Renal insufficiency with abnormal serum creatinine outside the age appropriate normal range;
- •Serum electrolytes (sodium, potassium, magnesium) outside the age appropriate normal range;
- •Clinically significant abnormal laboratory values outside the age appropriate normal range;
- •Hypersensitivity to cholinergic drugs;
- •Uncontrolled asthma.
- •Cardiovascular
- •Myocardial infarction or unstable angina within the 6 months prior to Visit 1 (screening);
- •History of more than one myocardial infarction during the last 5 years;Cardiomyopathy;Myocarditis;Severe hypotension; Severe hypertension requiring treatment with more than 2 drugs;Bradycardia (frequency of heart beat < 50/minute);Tachycardia (frequency of heart beat > 90/minute);Presence of AV block (type II / Mobitz II and type III);Congenital long QT syndrome;Sinus node dysfunction; Prolonged QTcB-interval (males > 450 msec; females > 470 msec);Presence of U wave.
- •Psychiatric
- •Axis I diagnosis within 1 year prior to study entry;Previous diagnosis of bipolar affective disorder or schizophrenia;Current alcohol or substance abuse or dependence;Metabolic or toxic encephalopathy or dementia due to a general medical condition;Geriatric Depression Score (GDS) > 5 at Visit 1 (screening).
- •Neurological
- •Stroke within the 6 months prior to Visit 1 (screening) or concomitant with onset of dementia; Tumours, subdural haematoma or other space-occupying processes on CT/MRI; Head trauma with loss of consciousness within 1 year of the onset of dementia;Head trauma with loss of consciousness concurrent with the onset of dementia;Onset of dementia within 1 year following cardiac arrest, surgery with general anaesthetic or resuscitation;Degenerative central nervous system conditions e.g. Huntington’s disease (Huntington’s chorea), Creutzfeld-Jakob disease, Parkinson’s disease, etc.;Genetic cognitive impairment e.g. Trisomy 21 (Down’s syndrome);Wernicke’s encephalopathy;Acute or chronic central nervous system infection including tertiary syphilis;Epilepsy.
- •Previous MedicationHas previously received:
- •Any acetylcholinesterase inhibitor in the 3 months before study entry;
- •Any experimental drug 3 months before Visit 2 (baseline);
- •Nootropics 1 month before Visit 1 (screening);
- •Benzodiazepines administered on a chronic basis;
- •Antipsychotics (unless prescribed for sleep disturbances) in the 3 months preceding study entry. If prescribed for sleep disturbance, then
研究者
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