EUCTR2009-017801-12-BG进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-384 in Subjects with Mild-to-Moderate Alzheimer's Disease.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- 性别
- All
入选标准
- •1. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
- •2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
- •3. Subject meets the NINCDS/ADRDA criteria for probable AD.
- •4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
- •5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score = 10 at Screening Visit 1.
- •6. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subect is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and 12-lead ECG.
- •7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
- •8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
- •9. Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
- •10. Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficent visual, hearing and graphomotor skills to complete procedures.
- •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
- •1. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
- •2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
- •3. Subject meets the NINCDS/ADRDA criteria for probable AD.
- •4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
- •5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score = 10 at Screening Visit 1.
- •6. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subect is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and 12-lead ECG.
- •7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
- •8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
- •9. Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
- •10. Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficent visual, hearing and graphomotor skills to complete procedures.
- •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
- •1. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
- •2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
- •3. Subject meets the NINCDS/ADRDA criteria for probable AD.
- •4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
- •5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score = 10 at Screening Visit 1.
- •6. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subect is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and 12-lead ECG.
- •7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
- •8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
- •9. Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
- •10. Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficent visual, hearing and graphomotor skills to complete procedures.
- •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. Subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
- •2. Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
- •3. Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, exluding nicotine, within 2 years prior to Screening Visit 1.
- •4. In the opionion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
- •5. The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
- •6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
- •1. Subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
- •2. Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
- •3. Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, exluding nicotine, within 2 years prior to Screening Visit 1.
- •4. In the opionion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
- •5. The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
- •6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
- •1. Subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
- •2. Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
- •3. Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, exluding nicotine, within 2 years prior to Screening Visit 1.
- •4. In the opionion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
- •5. The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
- •6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
研究者
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