NCT01843075Unknown2 期
Evaluating the Effects of the Novel GLP-1 Analogue, Liraglutide, in Patients With Mild Alzheimer's Disease (ELAD Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- The change in cerebral glucose metabolic rate
研究概览
简要总结
This is a 12-month, multicentre randomised double-blind placebo-controlled Phase IIb study in patients with mild Alzheimer's dementia (AD). Patients will be randomised on a 1:1 ratio to receive liraglutide or matching placebo.
详细描述
The investigators aim to recruit patients with mild Alzheimer's dementia as defined by the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) Criteria for Probable Alzheimer's Dementia or meeting Dubois criteria for early AD, with Mini Mental State Evaluation score of at least 20 out of a maximum of 30 and a CDR Global score of 0.5 or 1.
.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving and capacity to give informed consent
- •An individual who can act as a reliable study partner with regular contact (combination of face to face visits / telephone contact acceptable) who has sufficient subject interaction to provide meaningful input into rating scales and, if necessary, supervise or perform the injections, as judged by the investigator
- •Diagnosis of Probable Alzheimer's disease according to Dubois criteria (Dubois, Feldman et al. 2007) or National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- •Age from 50 years
- •Mini-Mental State Examination (MMSE) score of ≥20 and CDR-Global score of 0.5 or 1
- •Rosen Modified Hachinski Ischemic score ≤4
- •On stable medication for 2 months before the screening visit; on or off cholinesterase inhibitors
- •Fluency in English and evidence of adequate premorbid intellectual functioning
- •Likely to be able to participate in all scheduled evaluations and complete all required tests
排除标准
- •Patients on treatment for diabetes mellitus
- •Any contraindications to the use of liraglutide as per the Summary of Product Characteristics (hepatic impairment, renal impairment with CKD stage 4 and above (eGFR <30 ml/min/1.73m2), inflammatory bowel disease). Patients with eGFR less than 45 ml/min/1.73m2 will have the renal function monitored very closely
- •Significant neurological disease other than AD that may affect cognition
- •MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDS-AIREN criteria
- •Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- •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
- •History of epilepsy, where seizures or treatment could have contributed to cognitive impairment
- •Treatment with immunosuppressive medications (e.g. systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last 3 years
- •Myocardial infarction within the last 1 year
- •History of cancer within the last 5 years, except localised skin cancer
- •Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the patient
- •History of alcohol or drug dependence or abuse within the last 2 years
- •Current use of anticonvulsant, anti-Parkinson's, anticoagulant (excluding the use of aspirin 325 mg/day or less) or narcotic medications. Subjects on anticoagulants will be allowed, but will not have an arterial line inserted
- •Use of experimental medications for AD or any other investigational medication or device within 60 days. Patients who have been involved in a monoclonal antibody study are excluded unless it is known that they were receiving placebo in that trial
- •Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial
- •Patients with a personal or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine neoplasia type 2 (MEN2)
- •Any contraindications to MRI scanning
研究组 & 干预措施
Liraglutide
Experimental
Daily administration of 1.8 mg liraglutide by subcutaneous injection
干预措施: Liraglutide (Drug)
Placebo
Placebo Comparator
Daily administration of matched placebo by subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
The change in cerebral glucose metabolic rate
时间窗: 12 months
The change in cerebral glucose metabolic rate from baseline to follow up (12 months) in the treatment group compared with the placebo group.
次要结局
- The change in z-scores for the ADAS Exec, MRI changes, microglial activation, and CSF markers(12 months)
- The incidence and severity of treatment emergent adverse events(12 months)
- The change in tau deposition(12 months)
- The change in microglial activation(12 months)
- The change in cortical amyloid(12 months)
研究者
研究点 (1)
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