JPRN-jRCT2080223117已完成2 期
A Study to Evaluate Safety, Tolerability, and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria for Mild Cognitive Impairment due to Alzheimer's Disease
- •- Intermediate likelihood:
- •1.Subjects who meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment due to Alzheimer's disease - intermediate likelihood
- •2.Subjects who have a CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline
- •3.Subjects who report a history of subjective memory decline with gradual onset and slow progression over the last one year before Screening; MUST be corroborated by an informant
- •Key Inclusion Criteria for Mild Alzheimer's Disease Dementia:
- •4.Subjects who meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
- •5.Subjects who have a CDR score of 0.5-1.0 and a Memory Box score of 0.5 or greater at Screening and Baseline
- •Inclusion Criteria that must be met by all subjects:
- •6.Subjects with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale - IV Logical Memory II (WMS-IV LMII):
- •a.Less than or equal to 15 for age 50 to 64 years
- •b.Less than or equal to 12 for age 65 to 69 years
- •c.Less than or equal to 11 for age 70 to 74 years
- •d.Less than or equal to 9 for age 75 to 79 years
- •e.Less than or equal to 7 for age 80 to 90 years
- •7.Positive amyloid load as indicated by PET or CSF assessment
- •8.Age between 50 and 90 years, inclusive
- •9.Mini Mental State Examination (MMSE) score equal to or greater than 22, and equal to or less than 30, at Screening and Baseline
- •10.Body Mass Index (BMI) greater than 17 and less than 35 at Screening
- •11.Females must not be pregnant or lactating, and specified contraceptive precautions must be followed
- •12.Subjects on acetylcholinesterase inhibitor or memantine therapy for Alzheimer's disease (AD) must be on a stable dose for at least 12 weeks prior to baseline
- •13.Subjects must have identified caregivers/informants
- •14.Subjects must provide written informed consent
排除标准
- •1.Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD
- •2.History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
- •3.Any psychiatric diagnosis or symptoms, (e.g., hallucinations, major depression, or delusions) that could interfere with study procedures in the subject
- •4.Contraindications to MRI scanning, including cardiac pacemaker/ defibrillator, ferromagnetic metal implants, e,g., in skull and cardiac devices other than those approved as safe for use in MR scanners
- •5.Evidence of other clinically significant lesions that could indicate a dementia diagnosis other than AD on brain MRI at Screening, or other significant pathological findings on brain MRI at Screening
- •6.A prolonged QT/QTc interval (QTc greater than 450 ms) as demonstrated by a repeated electrocardiogram (ECG)
- •7.Certain other specified medical conditions
- •8.Severe visual or hearing impairment that would prevent the subject from performing psychometric tests accurately
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