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临床试验/NL-OMON54997
NL-OMON54997已完成3 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). - ANAVEX2-73 AD study

Anavex Life Sciences Corp.0 个研究点目标入组 30 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
已完成
入组人数
30
研究概览入排标准研究者记录与标识符相似试验

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

  • •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
  • •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 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.

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
  • •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
  • •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 weeks 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).
  • 另有 2 项未显示

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