EUCTR2019-003302-27-NL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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •1.Patients aged 60 to 85 years, inclusive, with a NIA-AA 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.At least one of the following criterion must be utilized to support AD diagnosis:
- •a.Historical records of amyloid CSF assessment or
- •b.Historical records of PET scan (amyloid scan or FDG-PET) or
- •c.Historical CT or MRI scan within 18 months of screening,
- •which are consistent with a diagnosis of AD. CSF collection or PET scan would be required as part of the screening process unless historical records (CSF or PET) are available, except for participants in Australia and United Kingdom (UK).
- •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 or other AD medication (e.g. memantine), or OTC supplements/nutraceuticals used to treat AD, dose(s) must be stable for at least 90 days before screening.
- •8. If taking a 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
- •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 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 (e.g., Amitriptyline, Amoxapine, Desipramine, (Norpramin) Doxepin, Imipramine (Tofranil), Nortriptyline (Pamelor), Protriptyline (Vivactil), Trimipramine (Surmontil)).
- •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 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 prescrip
研究者
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