Alzheimer's Disease. MedDRA version: 14.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. 2. The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. 3. The subject meets the NINCDS/ADRDA criteria for probable AD. 4. The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1. 5. The subject has a Cornell Scale for Depression in Dementia (CSDD) score = 10 at Screening Visit 1. 6. The subject has a Modified Hachinski Ischemic Scale (MHIS) score of = 4 at Screening Visit 1. 7. With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). 8. The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1. The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia. 2. The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator. 3. The subject has a history of any significant neurologic disease other than AD including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. 4. In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness. 5. The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the dose-response relationship with respect to the efficacy of symptomatic treatment and safety of three doses of ABT-126 in subjects with mild to moderate AD. The primary efficacy measure is the Alzheimer's Disease Assessment Scale – cognitive subscale (ADAS-Cog).;Secondary Objective: Not Applicable;Primary end point(s): English ADAS-cog: Alzheimer's Disease Assessment Scale-Cognition portion.;Timepoint(s) of evaluation of this end point: Screening Visit 1 & 2, Day -1, and Weeks 4, 8, 12, 18, & 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): MMSE, CIBIC-plus, NPI, ADCS-ADL, DEMQOL, RUD-Lite, PPQSA, WMS-III (Wechsler Memory Scale-III Working Memory Index), EQ-5D-5L and EQ-5D-3L Proxy & ADAS-cog 13-item total score.;Timepoint(s) of evaluation of this end point: MMSE & ADAS-cog 13 item scored at visits: Screening Visit 1 and 2, Day -1, Weeks 4, 8, 12, 18 & 24/Premature Discontinuation. CIBIC-plus & NPI scored at visits: Day -1, Weeks 4, 12, & 24/Premature Discontinuation. ADCS-ADL scored at visits: Screening Visit 1, Day -1, Weeks 4, 12 & 24/Premature Discontinuation. DEMQOL scored at visits: Day -1, Weeks 12 & 24/Premature Discontinuation. RUD-Lite scored at visits: Day -1 & Week 24/Premature Discontinuation. PPQSA scored at visits: Screening Visit 2, Weeks 8 & 24/Premature Discontinuation. WMS-III scored at visits: Screening Visit 2, Weeks 8 & 18. EQ-5D-5L and EQ-5D-3L Proxy scored at visits: Day -1 and Week 24/Premature Discontinuation. | — |
Countries
Poland, Russian Federation, South Africa, Ukraine, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed