EUCTR2019-003302-27-DE进行中（未招募）1 期
A Phase 2b/3, Double-Blind, Randomised, Placebo-Controlled 48-week Safety and Efficacy trial of ANAVEX2-73 for the Treatment of Early Alzheimer’s Disease (AD) - In the treatment of early AD: A Phase 2b/3 study to evaluate the safety and efficacy of Anavex2-73
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 509
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
- •Inclusion Criteria:
- •1.Patients aged 60 to 85 years, inclusive, with a 2011 NIA-AA criteria for diagnosis of mild cognitive impairment (MCI) due to AD or early stage mild dementia due to AD. AD diagnosis must be made by an appropriately qualified board-certified or equivalent medical specialist.
- •2.Additional criteria can be either:
- •a.Historical records of amyloid CSF assessment compatible with AD that meets at least one of the following criteria:
- •i. Cut off values of <1054 pg/mL for Aß42, >213 pg/mL for tTau, >21.3 pg/mL for pTau181, and <0.064 for Aß42/Aß40 ratio, according to the automated Elecsys® CSF biomarkers assays (Roche Diagnostics) or comparable commercially used CSF assays OR
- •ii.CSF pTau181 is > 27 pg/ml (irrespective of the Aß42/Aß40 ratio) OR
- •b.Historical records of PET scan within 36 months of screening (amyloid scan or FDG-PET) OR
- •c.Historical CT or MRI scan within 18 months of screening (Australia/UK only), which are consistent with a diagnosis of AD according to NIA-AA 2011 criteria OR
- •d.CSF profile compatible with AD that meets at least one of the following criteria:
- •i.Cut off values of <1054 pg/mL for Aß42, >213 pg/mL for tTau, >21.3 pg/mL for pTau181, and <0.064 for Aß42/Aß40 ratio, according to the automated Elecsys® CSF biomarkers assays (Roche Diagnostics) or comparable commercially used CSF assays; OR
- •ii.CSF pTau181 is >27 pg/ml (irrespective of the Aß42/Aß40 ratio).
- •3.Mini Mental State Examination (MMSE) score between 20-28, inclusive at both the Screening Visit and the Randomization Visit.
- •4.Free Recall score =17 or Total Recall score <40 on the Free and Cued Selective Reminding Test (FCSRT).
- •5.Participants are either outpatients, or residents of an assisted-living facility. Participant has a designated study partner, who spends at least 10 hr per week with the participant, in order that assessments (e.g., carer burden instruments) are completed with true knowledge of the participant.
- •6.No suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 3 months (i.e., active suicidal thought(s) with intent but without specific plan, or active suicidal thought(s) with plan and intent) OR suicidal behavior in the past 2 years (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- •7.If taking an acetylcholinesterase inhibitor and/or another medication for AD (e.g., memantine), or over-the-counter (OTC) supplements/nutraceuticals used to treat AD, dose(s) must be stable for at least 90 days prior to screening.
- •8.If taking psychoactive or anti-seizure medications, dose must be stable for at least 90 days prior to screening.
- •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 68
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 382
排除标准
- •Exclusion Criteria:
- •1.Patients who have a progressive medical or neurological condition that in the opinion of the investigator would interfere with the conduct of the study. Exception: If diagnosed with seizures, must be on stable anti-seizure medication for at least 3 months prior to screening.
- •2.Current clinically significant systemic illness that is likely to result in deterioration of the patient’s condition or affect the patient’s safety during the study.
- •3.History or clinically evident stroke or clinically significant carotid or vertebrobasilar stenosis or plaque.
- •4.History of neurologic (e.g., stroke, traumatic brain injury) or psychiatric condition that the investigator deems may interfere with interpretability of data.
- •5.History of untreated thyroid disorder, Type 1 diabetes, and insulin dependent or uncontrolled Type II diabetes, as determined by the investigator (e.g., non-insulin-controlled Type II diabetes, whose HbA1c value is higher than 8.0%).
- •6.If a participant has a Body Mass Index (BMI) > 35, no co-morbidities related to weight that would preclude safe participation in the study in the opinion of the investigator.
- •7.History of clinical hepatic dysfunction.
- •8.Current symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hematological or hormonal disorders.
- •9.Indication of liver disease, defined by serum levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3x upper limit of normal (ULN) as determined during screening.
- •10.Significant history of drug addiction (with the exception of nicotine dependence) or abuse (including alcohol, as defined in DSM-5 or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening. Prescription medication yielding a positive drug screen are acceptable except for tricyclic antidepressants.
- •11.Clinically significant infection within the last 30 days prior screening (e.g., chronic persistent or acute infection, urinary tract infections (UTI)).
- •12.Treatment with tricyclic antidepressants within 60 days prior to screening.
- •13.Treatment with immunosuppressive medications (e.g., systemic corticosteroids), within 90 days prior to screening (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted), or chemotherapeutic agents for malignancy within the last 3 years.
- •14.Myocardial infarction within the last year.
- •15.History of cancer within the last 3 years, with the exception of basal cell carcinoma and non-metastatic squamous cell carcinoma of the skin and prostate cancer with currently normal PSA.
- •16.Other clinically significant abnormality on physical, neurological, laboratory, or electrocardiogram (ECG) examination (e.g., atrial fibrillation) that could compromise the study or be detrimental to the participant.
- •17.Hemoglobin < 11 g/dL.
- •18.Smoking > 1 pack of cigarettes per day (as assessed for the 30 days prior to screening).
- •19.Alcohol use of more than 2 drinks per day.
- •20.Current use of over-the-counter (OTC) supplements or nutraceuticals unless they are on stable dose for at least 3 months prior to screening and are documented in the eCRF.
- •21.Use of over the counter (OTC) or prescription medication for sleep on 2 or more occasions per week.
- •22.Being treated with psychoactive medications on a stable dose for less t
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