EUCTR2007-004918-14-FI进行中（未招募）不适用
A 12-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE IMPACT OF DONEPEZIL HYDROCHLORIDE (ARICEPT®) ON BEHAVIORAL AND PSYCHOLOGICAL SYMPTOMS IN PATIENTS WITH SEVERE ALZHEIMER’S DISEASE
Pfizer Inc, 235 East 42nd Street, New York,NY 100170 个研究点目标入组 200 人开始时间: 2008年3月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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 Age range: Patients = 50 years.
- •2 Sex distribution: both men and women. Women must be two (2)-years post-menopausal or surgically sterile.
- •3 MMSE scores between 1 and 12 (inclusive).
- •4 Clinically significant behavioral pathology as measured by the Cornell Scale for Depression in Dementia(CSDD), defined as a total score on the CSDD of 5 or greater with at least one item rated 2 (severe) within the domains of Mood-Related Signs(Anxiety, Sadness, Lack of Reactivity, Irritability) or Behavioral Disturbances(Agitation, Retardation, Multiple Physical Complaints, Loss of Interest).
- •5 Diagnostic evidence of probable or possible Alzheimer’s disease (DSM-IV and NINCDS/ADRDA) made or confirmed by the site physician at the time of the screening visit. This evidence must be fully documented in the patient’s file prior to the baseline visit.
- •6 CT or MRI within the last 36 months consistent with a diagnosis of Alzheimer’s disease without any other clinically significant comorbid pathologies found. A copy of the report will be required and should be appended to the case report form. If there has been a significant change in clinical status suggestive of stroke or other possible neurological disease with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated if considered appropriate by the investigator.
- •7 Prior use of cholinesterase inhibitors (Aricept®, Exelon®, Cognex®, Reminyl/Razadyne®, metrifonate, physostigmine) and memantine is allowed, provided that the medication was discontinued at least 3 months prior to screening and that it was not discontinued for the purpose of enrolling the patient in the study.
- •8 Functional Assessment Staging (FAST) score >6a.
- •9 Patients residing in the community, assisted living facilities (ALF)
- •or skilled nursing homes.
- •10 The patient must be expected to complete all procedures scheduled during the Screening and Baseline visits including all efficacy parameters. Patients must have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the medication schedule. For patients residing in assisted living facilities or skilled nursing homes, the reporting caregiver may be a professional staff member, provided he or she meets the criteria in 8.2.11, and study visits may take
- •place in the facility if the study site staff finds this preferable to facilitate the smooth conduct of the study.
- •11 The caregiver must be a constant and reliable informant with a minimum of three days per week direct contact with the patient (for at least 4 hours per day during waking hours). This contact is necessary to ensure accurate reporting of the patient’s behavior.
- •12 Patients with stable Type I (Insulin-Dependent) or Type II diabetes are eligible provided they are monitored regularly prior to and during the study to ensure adequate glucose control.
- •13 Clinical laboratory values within normal limits, and within the sponsor’s guidelines, or abnormalities considered not clinically significant by the investigator and sponsor.
- •14 Patients with controlled hypertension (sitting diastolic BP < 95mmHg and/or sitting systolic BP <160 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study.
- •15 Patients with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 month
排除标准
- •1 Age range: Patients < 50 years.
- •2 MMSE score of <1 or >12.
- •3 FAST score of < 6a.
- •5 Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance).
- •6 Patients with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors.
- •7 Patients without a reliable caregiver (caregiver responsibilities are described in Section 8.2.11), or patients or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study.
- •8 Patients with clinically significant obstructive pulmonary disease or asthma, untreated or not controlled by treatment within 3 months prior to screening.
- •9 Patient’s with recent (< 2 years) hematologic/oncologic disorders
- •(mild anemia allowed).
- •10 Evidence of active, clinically significant and unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
- •11 Patients with a current DSM-IV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than Alzheimer’s disease (as per DSM-IV). Patients with CSDD scores >19 will be considered to have MDD and are
- •12 Patients with dementia complicated by other organic disease (DSM 290.30 or 290.11) are excluded; depressive symptoms and delusions are common in Alzheimer’s disease, but patients with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded.
- •13 Patients with vascular dementia (See Appendix IIIA) or dementia complicated by tertiary syphilis
- •14 Patients with a known or suspected history of alcoholism or drug abuse (within the past 10 years).
- •15 Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
研究者
相似试验
进行中（未招募）
1 期
A 12-Week, Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients with Type 2 Diabetes MellitusEUCTR2008-004207-63-DEEli Lilly and Company, Indianapolis300
进行中（未招募）
不适用
A 12-Week, Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients with Type 2 Diabetes MellitusEUCTR2008-004207-63-GBEli Lilly and Company, Indianapolis300
进行中（未招募）
不适用
A 12-Week, Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients with Type 2 Diabetes MellitusEUCTR2008-004207-63-ATEli Lilly and Company, Indianapolis300
进行中（未招募）
不适用
A 12-week clinical double-blind, randomised study of vitamin D versus placebo in patients with chronic kidney disease stage 3-4 (CHICK).Chronic renal failure, stage 3-4MedDRA version: 14.0Level: PTClassification code 10038444Term: Renal failure chronicSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2011-002586-38-SERenapharma AB100
进行中（未招募）
不适用
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate /Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets versus Fenofibrate or Simvastatin Monotherapies in Subjects with Abnormal Levels of Fats(lipids) in the Blood and at High Risk of Cardiovascular Disease.MedDRA version: 15.1Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 100000004861DyslipidemiaEUCTR2011-005924-16-PLAbbott Laboratories Ireland Limited600