EUCTR2017-001800-31-FI进行中（未招募）1 期
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF MTAU9937A IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
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
入选标准
- •- Age between 50 and 80 years
- •- National Institute on Aging/Alzheimer’s Association core clinical criteria for probable AD dementia or mild cognitive impairment (prodromal AD)
- •- Evidence of the AD pathological process, by a positive amyloid assessment either on cerebrospinal fluid Aß1-42 OR amyloid positron emission tomography (PET) scan. Historical amyloid PET scans may be accepted in some cases
- •- Mild AD symptomatology, as defined by a screening Mini-Mental State Examination score of >= 20 points and Clinical Dementia Rating (CDR) -Global Score of 0.5 or 1
- •- Abnormal memory function at screening
- •- Availability of a person with sufficient contact with the patient to be able to provide accurate information on the patient’s cognitive and functional ability
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 280
排除标准
- •- Pregnant or breastfeeding
- •- Inability to tolerate magnetic resonance imaging (MRI) procedures or contraindication to MRI
- •- Able to undergo either PET imaging or lumbar dural puncture, or both, and patients with contraindications to both procedures are ineligible
- •- Residence in a skilled nursing facility
- •- Any serious medical condition or abnormality in clinical laboratory tests that remains abnormal on retest and, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree
- •- Any evidence of a condition other than AD that may affect cognition
- •- Substance abuse meeting criteria for alcohol, cannabis, phencyclidine, other hallucinogen, inhalant, opioid, sedative, hypnotic, anxiolytic, or stimulant use disorder of any severity (per the Diagnostic and Statistical Manual of Mental Disorders, Version 5) within the past 2 years
- •- Use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater and any passive immunotherapy (immunoglobulin) against tau, except use of RO7105705 in Genentech Study GN39058, as long as the last dose was at least 90 days prior to screening
- •- Use of any passive immunotherapy (immunoglobulin) against Aß, unless the last dose was at least 1 year prior to screening and any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline
- •- Any previous treatment with medications specifically intended to treat Parkinsonian symptoms or any other neurodegenerative disorder within 1 year of screening
- •- Systemic immunosuppressive therapy within 12 months of screening through the entire study period
- •- Typical antipsychotic or neuroleptic medication within 6 months of screening
- •- Daily treatment with any of the following classes of medication, except for intermittent short-term use, which is permitted except within 2 days or 5 half-lives (whichever is longer) prior to any COA such as atypical antipsychotics, Opiates or opioids ,Benzodiazepines, barbiturates, or hyponotics and any medication with centrally-acting antihistamine or anticholinergic activity
- •- Stimulant medications, unless the dose has been stable within the 6 months prior to screening and is expected to be stable throughout the study
研究者
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