ACTRN12621000726853招募中2 期
A double-blind, placebo controlled, randomised phase II trial of probucol in Alzheimer’s disease: The impact on cognition
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 314
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •18 years of age or older,
- •A positive amyloid biomarker (PET scan) indicative of AD pathology,
- •Mini-mental-state examination (MMSE) score of 20 or greater,
- •Free and cued selective reminding test (FCSRT) cueing index score of less than or equal to 0.79, OR a free recall of less than or equal to 17.
- •Clinical Dementia Rating (CDR) global score of 0.5 or 1.0.
- •A study partner (partner/spouse/carer) consents to the minimum requirements:
- •Study partner will attend at least one screening visit
- •Study partner will be available via phone or in person to provide information to the study as required
排除标准
- •A patient who meets any of the following exclusion criteria will not be eligible for inclusion in the study:
- •1. Recorded number of falls in previous 12 months and during trial. Participants who report multiple falls with potential loss of consciousness will be excluded
- •2. History of QTc-induced prolongation and willingness to limit use of over-the- counter, or prescription medicines (e.g. anti-histamines) known to prolong QTc interval. Corrected QT interval using Bazett's formula (QTcB) interval > 490 msec for males, or 500 msec for females, as detected by ECG and confirmed by physician. Participants who have a history of QTc-induced prolongation and are unwilling to limit use of medication will be excluded.
- •3. Evidence of abnormal cardiac function as defined by any of the following:
- •a. Myocardial infarction within 6 months of Cycle 1, Day 1
- •b. Symptomatic congestive heart failure (New York Heart Association > Class II)
- •c. Unstable angina
- •d. Unstable atrial fibrillation including paroxysmal atrial fibrillation. Medicated, stable atrial fibrillation will be assessed by the study doctor on a case-by-case basis.
- •e. Frequent multifocal ventricular arrhythmia
- •4. Unable to swallow oral medications.
- •5. Gastrointestinal conditions that, in the opinion of the Investigator, could affect the absorption of study drug.
- •6. Use of any prescription or non-prescription (including herbal) medications, or consumption of foods known to be strong QT prolongation within 7 days prior to the first administration of Lorelco™ and for the duration of the study . These include (but are not limited to):
- •a. Medications
- •b. With significant central anticholinergic effects,
- •c. Sedatives,
- •d. Antiparkinsonian medications that cannot be stopped prior to study entry,
- •e. Any investigational treatment for AD
- •7. ‘Current diagnosis of cancer (within 3 years) and/or undergoing chemotherapy, with exception to cancers of the skin such as basal or squamous cell carcinoma in situ of the skin.
- •8. Significant head injury within 5 years
- •9. Electrolyte imbalance (e.g. on high steroids, pituitary tumours, and Addison disease)
- •10. Hypokalaemia, hypomagnesaemia and hypocalcaemia
- •11. They have other neurologic or psychiatric diagnosis that in the opinion of the investigator could interfere with cognitive function,
- •12. Major surgery is planned during the conduct of the trial, or a clinical event has occurred in the six months preceding study inclusion that may compromise ability to participate for the duration of the study,
- •13. Evidence of stroke where the clinical effects are clearly temporally related to the onset of cognitive impairment.
- •14. Current diagnosis with a psychiatric disorder, or taking psychotropic medications,
- •15. Other excluded medications will be those that are;
- •Specifically contraindicated with Probucol, based on historic clinical indications for the treatment of cardiovascular disease. Stable use (for at least 3 months) of cholinesterase inhibitors and memantine will be allowed.
- •Patients on high dose loop-diuretics or thiazide diuretic medications, will be excluded if taking maximum dose of furosemide or Bendroflumethiazide
- •16. Self-reported human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B (HBsAg) or hepatitis C virus (HCV).
- •17. Any inflammatory or chronic pain condition that necessitates regular use of opiates/opioids,
- •18. Major surgery within 28 days of Cycle 1, Day 1, or minor surgical procedures within 7 days of Cycle 1, Da
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