NCT02249403已完成2 期
Efficacy and Safety of 6, 12, 24, and 36 mg Tid po and 36 mg Bid po Talsaclidine (Free Base) for 12 Weeks in a Double-blind, Randomised, Placebo-controlled Parallel Group Comparison in Patients With Mild to Moderate Dementia of Alzheimer Type
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 362
- 主要终点
- Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)
研究概览
简要总结
The objective of this trial was to assess the dose-response relationship of symptomatic efficacy of talsaclidine base on ADAScog and to assess safety and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, age: over 40 years (lower age if genetic Dementia of Alzheimer Type (DAT) is documented. Patients over 85 years need to be in a clinically stable state (investigator's judgement)
- •Patient's educational level is > 4 years
- •Patient is able to understand the patient information and give informed consent
- •Patient has given written informed consent in accordance with Good Clinical Practice and local legislation
- •Patient has a non-demented relative or care giver who is willing to support the clinical trial; his/her written informed consent is optional
- •Body weight: within +/- 30% of normal weight (Broca index)
- •Diagnosis of DAT by the National Institute of Neurological and communicative Disorders-Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria
- •MMS-score 10 - 24 inclusive
- •Rosen ischemia score is lower or equal to two
- •Patient is able to complete the trial examinations, to hear, speak, read and write in a basic way and primary sensorial functions are intact
排除标准
- •Any dementia of vascular genesis (excluded by Rosen ischemia score > 2)
- •Magnetic Resonance Imaging (MRI) or Computer Tomogram (CT) (more recent than 12 months; if a MRI of CT recording is performed more than 12 months before study entry, it must be repeated) findings make the diagnosis of DAT unlikely
- •Any stroke history
- •All secondary dementia (exclusion diagnosis defined by the NINCDS-ADRDA criteria) as a late complication of:
- •Cranio-cerebral trauma
- •Intoxication (incl. history of alcohol and drug abuse)
- •Cerebral infections (e.g. neurosyphilis)
- •Thyroid dysfunction
- •Cerebral dysfunction due to metabolic disorders (e.g. unstable thyroid dysfunction, or unstable insulin-dependent diabetes mellitus with hypo-/hyper-glycemic episodes)
- •Deficiency of vitamin B12 or folic acid as a reason of dementia
- •Brain tumour (A patient with an incidental tumour found on CT not felt to be clinically relevant may be included, i.e.: meningioma)
- •Down's syndrome, Parkinsonism, Huntington's chorea
- •Multiple sclerosis
- •Major depression defined by the Hamilton Depression Rating Scale (HAMD) 17 item scale (≥ 16)
- •Depressive pseudo dementia
- •Mental retardation
- •Hydrocephalus
- •Endogenous psychoses (schizophrenia)
- •Untreated or non-compensated hypertension (Blood Pressure systolic > 180 and/or diastolic > 110 mmHg)
- •Hypertension being treated with reserpine, clonidine or β-blockers (these cases have to be adjusted to therapy with e.g. calcium antagonists 4 weeks before start of treatment)
- •Severe heart failure (NYHA: III and IV)
- •Arrhythmias (Lown: II-IV, Electrocardiogram > 30 ventricular extrasystoles/hour, multifocal or multiform and repetitive forms of ventricular extrasystoles)
- •Bronchial asthma with phases of exacerbation or inducible by aspirin or other Nonsteroidal anti-inflammatory drugs
- •Severe diabetes mellitus: insulin dependent and not stabilised (patient with an HbA1c in normal range, clinically stable diabetes and any case of insulin dose ≤ 0.5 UI/kg/day may be included), or other metabolic diseases
- •Renal insufficiency: calculated creatinine clearance is less than 60 ml/min
- •Acute hepatic disorder (liver enzymes above 50 % upper normal limit)
- •Chronic hepatitis within the last two years (positive hepatitis titer, Hepatitis A Virus, Hepatitis B Virus, Hepatitis C Virus, cytomegalovirus, Epstein-Barr virus or abnormal immunological values (positive immunoglobulin M(IgM)/IgG) are allowed if all liver enzymes are within the normal range)
- •Recent history of liver disease (2 years) including drug intoxication (e.g. narcotics, cytostatics etc.)
- •Patients with obvious symptoms of dehydration
- •History of drug or alcohol abuse or dependence on other hepatotoxic agents (if a patient is permanently hospitalised and a drug screen performed at the beginning of hospitalisation, no additional drug screen is necessary)
- •Neoplasm currently active or likely to recur (except basal cell carcinoma)
- •Participation in another clinical trial within the last four weeks and re-entering from this or a previous talsaclidine trial
- •Pregnant and lactating woman, woman with childbearing potential not using an approved method of contraception
- •Insufficient compliance: in the investigator's opinion the patient or family is unable to comply with the protocol requirements
研究组 & 干预措施
Talsaclidine, 6 mg tid
Experimental
干预措施: Talsaclidine 6 mg (Drug)
Talsaclidine, 12 mg tid
Experimental
干预措施: Talsaclidine 12 mg (Drug)
Talsaclidine, 24 mg tid
Experimental
干预措施: Talsaclidine 24 mg (Drug)
Talsaclidine, 36 mg tid
Experimental
干预措施: Talsaclidine 36 mg (Drug)
Talsaclidine, 36 mg bid
Experimental
干预措施: Talsaclidine 36 mg (Drug)
Talsaclidine, 36 mg bid
Experimental
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)
时间窗: Baseline, week 12
次要结局
- Change in ADAScog (extension)(Baseline, week 4, 8 and 12)
- Change in ADAScog (Total)(Baseline, week 4, 8 and 12)
- Change in mini mental state (MMS)(Screening, week 12)
- Change in neuropsychiatric inventory (NPI)(Baseline, week 12)
- Change in Hamilton Depression Rating Scale(Screening, week 12)
- Change in instrumental activity of daily living (IADL)(Baseline, week 12)
- Change in living status rated on a 6-point verbal rating scale(Baseline, week 12)
- Change in clinician's global impression rated with Alzheimer's Disease cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)(Baseline, week 12)
- Number of patients with adverse events(up to 12 months)
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