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 |
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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 (latrepirdine) in Alzheimer’s disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) study with available Week 52 efficacy assessment data; at a minimum, the Week 52 Alzheimer’s Disease Assessment Scale – cognitive subscale (ADAS-cog) and Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) data must be available; 2. Are willing and able to give informed consent for study participation. If the patient is not competent, a mentally competent legally-acceptable representative must provide informed consent on their behalf, and the patient must provide verbal assent; 3. Have a caregiver who assists the patient, can oversee study drug administration, report adverse events, and provide written informed consent; 4. If female, are either a) of childbearing potential and compliant in using adequate birth control through 30 days after the last dose of study drug, or b) not of childbearing potential. Adequate birth control is defined as consistent practice of an effective and accepted method of contraception (hormone-based, intrauterine device, barrier contraception [e.g., condom or occlusive cap {diaphragm or cervical/vault caps} with spermicidal foam/gel/film/cream/suppository], vasectomized partner, or sexual abstinence) throughout the duration of the study. Women not of childbearing potential may have undergone menopause or permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Menopause is defined as 1 year without menses. If the patient’s menopausal status is in question, a follicle-stimulating hormone (FSH) level of > 40 milli-international units per milliliter (mIU/mL) must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented; 5. If male, are either a) of reproductive potential and compliant in using adequate birth control through 30 days after the last dose of study drug, or b) not of reproductive potential. Surgical sterilization must be documented. Adequate birth control for males is defined as a condom and spermicidal gel or foam, or a condom in combination with an acceptable method of contraception for a female partner as specified in inclusion criterion 4, or abstinence throughout the duration of the study; 6. Are capable of complying with study procedures, including being able to swallow the study drug tablets. |
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E.4 | Principal exclusion criteria |
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, which places the patient at undue risk, or may interfere with the ability to interpret safety information; 2. Are pregnant or breastfeeding females; 3. Plan to use bupropion, clozapine, or non-selective antihistamines such as chlorpheniramine and diphenhydramine, during this extension study; 4. Plan to participate in another study of an investigational product |
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E.5 End points |
E.5.1 | Primary end point(s) |
The safety of dimebon will be assessed by the frequency of serious adverse events, the frequency of discontinuation of dimebon treatment due to an adverse event, the frequency and severity of adverse events, as well as the frequency of new laboratory abnormalities. Safety measures include adverse events and clinical laboratory studies. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 49 |
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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All`immissione del farmaco in commercio in Italia o all`interruzione dello studio come in sez 9.8 del protocollo. End of trial defined as commercial availability in the patient`s country, or study termination as described in Section 9.8 of protoco |
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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 |