EUCTR2007-005118-37-DE进行中（未招募）不适用
Effect of ?-Secretase Inhibition on the Progression of Alzheimer’s Disease: LY450139 versus Placebo
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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]Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
- •[2]Has a Modified Hachinski Ischemia Scale score of =4
- •[3]Has an MMSE score of 16 through 26 at Visit 1
- •[4]Has a Geriatric Depression Scale (GDS) score of =6
- •[5]A magnetic resonance imaging (MRI) or computerized tomography (CT) scan within the past 2 years has confirmed no findings inconsistent with a diagnosis of AD[6]Is at least 55 years old.
- •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
- •[1]Meets National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
- •[2]Does not have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications. Note: The caregiver must be able to communicate with site personnel and be willing to comply with protocol requirements, and in the investigator’s opinion must have adequate literacy to complete the protocol-specified questionnaires. Participants living in an assisted-living facility may be included if study medication intake is supervised and if regular contact with a caregiver who accompanies the patient is maintained.
- •[3]Is not capable of swallowing whole oral medications
- •[4]Has serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator’s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years
- •[5]Has a history within the past 5 years of a serious infectious disease affecting the brain, including neurosyphilis, meningitis, or encephalitis
- •[6]Has a history within the past 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen (PSA) post resection
- •[7]Has compromised renal function at Visit 1, as determined by creatinine clearance <30 mL/min based on Cockcroft-Gault calculation of creatinine clearance
- •[8]Has a history of chronic alcohol or drug abuse or dependence (using
- •DSM-IV TR criteria) within the past 5 years
- •[9]Requires the use of concomitant medications that prolong the QT/QTc
- •interval or has a known history of Long QT Syndrome or Brugada
- •Syndrome. Has ECG abnormalities obtained at Visit 1 or at predose
- •Visit 2 (baseline value) that, in the opinion of the investigator, are
- •clinically significant with regard to the patient’s participation in the
- •study; or has a QTc abnormality at Visit 1 or predose Visit 2 (baseline
- •value) as indicated by a mean QTc interval >458 ms if male or
- •>474 ms if female (calculate QTc using Bazett’s correction method;
- •see Section 6.3.2.2 for details on use of QTc for exclusion).
- •[10]Has evidence of significant active cardiac disease, uncontrolled hypertension, uncompensated congestive heart failure, or endocarditis
- •[11]Has potassium <3.2 mEq/L at Visit 1
- •[13]Has absolute lymphocyte count <0.5 GI/L at Visit 1
- •[14]Has platelets <75 GI/L at Visit 1
- •[15]Has a known history of HIV
- •[16]Has a history of clinically significant multiple or severe drug allergies
- •[17]At Visit 1, has alanine transaminase (ALT/SGPT) values =2 times the upper limit of normal (ULN) of the performing laboratory, aspartate transaminase (AST/SGOT) values =3 times the ULN, or total bilirubin values =2.0 times the ULN
- •[18]Requires or is expected to require use of excluded drugs during the study, in particular specific calcium-channel blockers, immune modulators, or immunosuppressants that are excluded from use in this t
研究者
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