Mild to moderate Alzheimer's Disease MedDRA version: 12.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Code: ABT-384
Pharmaceutical Form: Capsule*
CAS Number: 868623-40-9
Current Sponsor code: ABT-384
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharma
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the efficacy and safety of 2 doses levels of ABT-384 in subjects with mild-to-moderate Alzheimer's Disease.;Secondary Objective: None;Primary end point(s): ADAS-cog: Alzheimer's Disease Assessment Scale-Cognition portion. | — |
Countries
United Kingdom
Outcome results
None listed