ISRCTN15039674已完成未知
Multi-centre, blinded, randomised, controlled trial comparing different regimens of the antibiotics Doxycycline and Rifampin for treatment of Alzheimer's Disease
McMaster University (Canada)0 个研究点目标入组 500 人开始时间: 2006年10月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 500
研究概览
简要总结
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/22718435 2019 results in https://pubmed.ncbi.nlm.nih.gov/30909214/ (added 19/08/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Probable Alzheimer's disease
- •2. Aged 50 - 99 years old, either sex
- •3. Standardised Mini Mental State Examination (SMMSE) score 14 to 26 inclusive
- •4. Consenting patient (or Power of Attorney [POA] consents for patient)
- •5. Consenting caregiver
- •6. Sufficient English to complete standardised testing in English
- •7. May reasonably be expected to complete a one year trial
排除标准
- •1. Other neuro-degenerative diseases such as Lewy body, Parkinson's, fronto-temporal, Huntington's Chorea, Down's Syndrome or Creutzfeld Jacob Disease
- •2. Cognitive impairment due to acute cerebral trauma, subdural haematoma, injuries from chronic trauma, hypoxic cerebral damage
- •3. B12 deficiency, cancer or infections e.g. acquired immune deficiency syndrome (AIDS)
- •4. Endocrine deficiencies
- •5. Hypercalcemia, hypothyroidism, hyperparathyroidism, Cushing's syndrome, severe renal failure, poorly controlled diabetes mellitus, pituitary disease, etc.
- •6. Mental retardation
- •7. Significant cerebrovascular disease or multi-infarct dementia
- •8. Intra-cranial pathology, tumour or hydrocephalus
- •9. Co-existing medical conditions such as history of epilepsy or convulsions
- •10. Clinically significant psychiatric conditions or moderate to severe behavioural disturbances
- •11. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine diseases
- •12. History of drug or alcohol abuse
- •13. History of myasthenia gravis
- •14. Clinically significant cardiac disease such as cardiac surgery in the past six months, unstable angina or poorly controlled congestive heart failure, uncontrolled hypertension with systolic pressure greater that 180 mmHg or diastolic pressure greater that 110 mmHg
- •15. Anti-dementia treatments except donepezil, galantamine, rivastigmine, memantine, acetylsalicylic acid (ASA) up to 650 mg OD, Vitamin E 400 i.u., multi B vitamins, Ginko biloba, Cyclooxygenase Type II (Cox II) inhibitors or statins
- •16. Other investigational drugs
- •17. Long-term antibiotics
- •18. Allergy to doxycycline or rifampin
研究者
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