EUCTR2008-006337-27-GB进行中（未招募）不适用
A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,PARALLEL GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF PRX-03140 AS MONOTHERAPY INSUBJECTS WITH ALZHEIMER’S DISEASE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 236
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
- •Men or women with a clinical diagnosis of probable AD in
- •accordance with NINCDS-ADRDA criteria
- •MMSE score 16 to 24 inclusive at Screening and Visit 2
- •Age =50 and =90 years
- •Brain CT or MRI scan consistent with a primary diagnosis of AD within 12 months prior to Visit 2
- •Neurological examination without focal deficits (excluding changes
- •attributable to peripheral nervous system disease, trauma or
- •congenital birth deficits)
- •No history or evidence of any other CNS disorder that could likely
- •be interpreted as a cause of dementia: e.g. cerebrovascular disease
- •(stroke, hemorrhage), structural abnormality, epilepsy, infectious or
- •inflammatory/demyelinating CNS conditions, Parkinson’s disease
- •No diagnosis of possible, probable or definite vascular dementia in
- •accordance with NINDS-AIREN criteria
- •No history of significant psychiatric illness such as schizophrenia or
- •bipolar affective disorder that, in the opinion of the Investigator,
- •would interfere with study participation. Subjects with major
- •depressive disorder (according to DSM-IV-TR) successfully treated
- •with a stable dose of an antidepressant for at least 6 months prior to
- •Screening may be considered for the study
- •No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or clinical thyroid disease associated with abnormal thyroid function stimulating hormone (TSH) levels. Randomization may be offered to subjects with adequately treated thyroid disease or mild abnormalities in TSH levels without clinical consequence
- •Cognitive tasks prescribed for cognitive rehabilitation and performed under medical supervision are prohibited for 6 months prior to Visit 2, as well as for the duration of the study• Ability to comply with procedures for cognitive and other testing,
- •and to attend all scheduled study visits
- •Subject lives with, or has substantial periods of contact with, a
- •regular caregiver who is willing to attend all visits, oversee
- •compliance, and report on subject’s status (Note: a non-cohabitating
- •caregiver must spend sufficient time with the subject so that in the
- •opinion of the Investigator, the caregiver can reliably assess
- •cognitive function, ADLs, and report on the subject’s compliance
- •and health. As guidance, the ability for a caregiver to meet the
- •expected responsibilities for this study would normally require
- •spending at least 7 hours per week with the subject.)
- •Signed informed consent by the subject (and legal guardian, if
- •applicable)
- •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
- •Any co-morbidity or condition that, in the opinion of the
- •Investigator, may interfere with the assessments and procedures of
- •this protocol
- •Current or recent history (i.e., within 5 years prior to Screening) of
- •drug (with the exception of nicotine) or alcohol abuse or dependence
- •as defined by DSM-IV-TR criteria for substance-related disorders
- •Clinically significant laboratory abnormalities, including:
- •o Positive Hepatitis B or C serology
- •o ALT and/or AST, values >2.5 times the upper limit of
- •normal (ULN)
- •o Total bilirubin >1.2 x ULN (unless documented evidence
- •of Gilbert’s syndrome).
- •o Serum creatinine =2.0mg/dL (or calculated creatinine
- •clearance < 30mL/min)
- •The use of any investigational drug within 30 days of Visit 2
- •Intolerance or allergy to AchEIs (in the opinion of the Investigator)
- •Use of acetylcholinesterase inhibitors (AchEIs) for AD for >1 month
- •If subjects received an AchEI <1 month, the AchEI must have been
- •discontinued =2 months prior to Visit 2
- •Receipt of memantine within 2 months of Visit 2
- •Clinically significant ECG abnormalities (including QTc value >480
- •msec in men or >500 msec in women) in individuals not on pacemakers
- •History of myocardial infarction or coronary artery bypass graft
- •within 3 months of Screening, uncontrolled symptomatic atrial fibrillation or symptomatic ventricular arrhythmias
- •History of uncontrolled seizure disorder within 12 months of
- •Use of St. John’s wort, kava kava, ephedra, ginkgo biloba, or other
- •psychoactive herbal medications within 2 weeks prior to Screening
- •Use of the following prohibited medications: any MAO inhibitors,
- •bupropion, fluoxetine, paroxetine, quinidine
- •Prior receipt of PRX-03140
- •Planned surgery during the study period necessitating general
- •History or presence of gastrointestinal, hepatic, or renal disease or
- •other condition known to interfere with the absorption, distribution,
- •metabolism, or excretion of drugs
- •Any malignancy within 3 years of Visit 2 (exception: basal or localized squamous cell carcinoma of the skin or cervical cancer in situ, or well circumscribed carcinoma that has been completely surgically excised)
- •Pregnancy or lactation. Women of childbearing potential and
- •sexually active non-vasectomized men must agree to use a barrier
- •method of contraception during the entire study
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