NL-OMON48730已完成2 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 - TAURIE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Genentech
- 入组人数
- 20
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
- 18 至 99（—）
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 A*1*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
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
- •- 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 A*, 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
- •- Investigational biologic therapy (e.g., therapeutic proteins, monoclonal
- •antibodies, or other active or passive immunotherapy) within 1 year of
- •screening, or any expectation to require additional investigational biologic
- •therapy for the duration of the trial
- •- Any previous treatment with medications specifically intended to treat
- •Parkinsonian symptoms or any other neurodegenerative disorder within 1 year of
- •- 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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