E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001896 |
E.1.2 | Term | Alzheimer's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
• 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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is defined as the last visit of the last patient undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |