Alzheimer's Disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Sponsors
Medivation, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients eligible to participate in this CONNECTION PLUS Study (DIM14 Extension) are those who: 1. Have successfully completed 26 weeks of blinded treatment with available Week 26 efficacy assessment data (ADAS-cog, CIBIC plus, MMSE, ADCS-ADL, NPI, and the RUD Lite) in the CONNECTION Study (DIM14); at a minimum, the Week 26 ADAS-cog data must be available; 2. Are willing and able to give informed consent. If the patient is not competent, a legally-acceptable representative must provide informed consent on their behalf, and the patient should provide assent; 3. Are able to cooperate with study drug administration and safety assessments; 4. Ideally have a caregiver who assists the patient at least five days per week for at least three hours per day and has intimate knowledge of the patient’s cognitive, functional, and emotional states, and of the patient’s personal care. At a minimum the caregiver must reliably report any adverse events the patient experiences; 5. If female, must be surgically sterile or postmenopausal (for at least two years) or agree to use double-barrier methods of birth control; 6. If male, must agree to utilize double-barrier methods of birth control during the study and for at least 30 days following the last dose of study drug. The double-barrier method includes two of the following forms of contraception: condom, contraceptive sponge, diaphragm, or cervical ring with spermicidal gel or foam. 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: • Patients not eligible to participate in this CONNECTION PLUS Study (DIM14 Extension) are those who: 1. Have any major medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information; 2. Are pregnant or lactating females; 3. Plan to use bupropion, clozapine, or non-selective antihistamines during this extension trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of Dimebon in Alzheimer’s Disease (AD) patients who have successfully completed 26 weeks of blinded treatment in the CONNECTION protocol (DIM14).;Secondary Objective: • To characterize the effects of Dimebon over 12 months on two measures of cognition, the Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and the Mini-Mental State Examination (MMSE); • To characterize the effects of Dimebon over 12 months on a global measure of function, the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus); • To characterize the effects of Dimebon over 12 months on a measure of self care and daily function, the Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL); • To characterize the effects of Dimebon over 12 months on a measure of behavior, the Neuropsychiatric Inventory (NPI); • To characterize the impact of treatment with Dimebon over 12 months on a measure of health care utilization, the Resource Utilization in Dementia Lite (RUD Lite). ;Primary end point(s): The following assessments will be performed to monitor safety during the study: • Adverse events will be recorded at each visit; • Vital signs will be monitored at each clinic visit; • Physical examinations will be performed at Week 26 in the CONNECTION Study (DIM14). During this CONNECTION PLUS Extension study, physical examinations will be performed at routine quarterly intervals, at the End of Study and (if applicable) Early Termination visit, as well as required for evaluation of interval actual or potential adverse events; • Clinical laboratory testing; • ECG monitoring. | — |
Countries
France, Germany, Netherlands, Sweden, United Kingdom
Outcome results
None listed