ISRCTN89711766进行中（未招募）2 期
Evaluating the effects of the novel GLP1 analogue, Liraglutide, in patients with Alzheimer's Disease (ELAD study): a randomised, double-blind, placebo-controlled trial
Imperial College of Science, Technology and Medicine (UK)0 个研究点目标入组 206 人开始时间: 2013年11月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 206
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30944040 protocol (added 10/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male/female aged 50-85
- •2. Capable of giving and capacity to give informed consent
- •3. A carer who can act as a reliable study partner
- •4. Diagnosis of probable Alzheimer's disease according to NIAAA criteria
- •5. Mini-Mental State Examination (MMSE) score of =22
- •6. Rosen Modified Hachinski Ischemic score =4
- •7. On stable medication for 3 months on or off cholinesterase inhibitors
- •8. Fluency in English and evidence of adequate premorbid intellectual functioning.
- •9. Likely to be able to participate in all scheduled evaluations and complete all required tests.
排除标准
- •1. Any contraindications to the use of Liraglutide as per the Summary of Product Characteristics (hepatic impairment, renal impairment with CKD stage 3 and above, inflammatory bowel disease).
- •2. Significant neurological disease other than AD that may affect cognition.
- •3. MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regards to their dementia.
- •4. Diabetes mellitus.
- •5. Currently taking or having taken memantine on the 30 days prior to screening.
- •6. 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).
- •7. 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.
- •8. History of seizures, excluding febrile seizures in childhood.
- •9. 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.
- •10. Myocardial infarction within the last 1 year.
- •11. History of cancer within the last 5 years.
- •12. Other clinically significant abnormality on physical, neurological, laboratory, examination that could compromise the study or be detrimental to the patient.
- •13. History of alcohol or drug dependence or abuse within the last 2 years.
- •14. Current use of anticonvulsant, anti-Parkinson?s, anticoagulant (excluding the use of aspirin 325 mg/day or less) or narcotic medications.
- •15. 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.
- •16. Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial.
- •17. Patients with a personal or family history of medullary thyroid carcinoma (MTC) and patients with multiple endocrine neoplasia type 2 (MEN2).
研究者
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