EUCTR2005-005791-32-GB进行中（未招募）1 期
Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Mild/moderate dementia as evidenced by a screening Mini-Mental State Examination (MMSE) score of 12-24 inclusive
- •2. Capable of understanding written procedures and giving written informed consent.
- •3. Male and Female outpatients with Alzheimer’s disease The diagnosis should be established in accordance with the NINCDS-ADRDA classification1 for probable Alzheimer’s disease. Patients living in residential homes for the elderly will be excluded
- •4. Patients aged over 55 years
- •5. Patients who live with or have at least daily visits from a responsible carer
- •This includes a friend or relative. The carer should be capable of assisting with the patient’s medication, prepared to attend with the patient for assessment and willing to provide information about the patient. There may be more than one carer, however, the same carer should assess the patient throughout the study, wherever possible. If there is a local requirement, the responsible carer will sign the carer informed consent form confirming they are willing to help the patient during the study and willing to visit with them for each assessment
- •6. Written informed consent
- •Written consent should be obtained from the patient and responsible carer and countersigned by the responsible physician
- •7. Depending on the biomarker results from Plan A, a decision will be made whether or not to include a biomarker as an entry criterion for Plan B. If a biomarker inclusion criterion is required, it will only be added after approval as a substantial protocol amendment.
- •8. A negative screen for drugs of abuse, serum hepatitis B surface antigens, and hepatitis C
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Primary, secondary or pseudo- dementias
- •2. Concomitant medication, such as antipsychotics, anti-Parkinson’s drugs, anticonvulsants, cholinergic agents, NSAIDs, or Over-The-Counter medication other than approved by the Investigator
- •3. Excessive alcohol intake, malnourishment, use of antioxidant supplements; active smokers
- •4. Women of child-bearing potential or nursing mothers
- •5. Patients otherwise unsuitable for this study type, or feeling unable to comply with the restrictions required by the study
- •(The full list is given in Section 7.3 of the Study Protocol)
研究者
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