E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's Disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive decline, abnormal behaviour, and personality changes. |
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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 |
The primary objective of this open-label study is to evaluate the long-term safety of Alzhemed™ in patients with Alzheimer’s Disease (AD). |
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E.2.2 | Secondary objectives of the trial |
• Assess the long-term effect of Alzhemed™ on global cognitive functioning using the AD Assessment Scale, cognitive subscale (ADAS-cog) and the Mini Mental State Examination (MMSE) scale. • Assess the long-term effect of Alzhemed™ on global clinical status using the Clinical Dementia Rating Sum of Boxes (CDR-SB). • Assess the effect of a delay in the initiation of Alzhemed™ treatment on global cognitive functioning using the ADAS-cog and MMSE scales. • Assess the effect of a delay in initiation of Alzhemed™ treatment on global clinical status using the CDR-SB. • Assess the long-term effect of Alzhemed™ treatment on patterns of health care resource utilization using the RUD Lite© instrument. • Assess the effect of a delay in initiation of Alzhemed™ treatment on patterns of health care resource utilization using the RUD Lite© instrument. • Assess changes in cognitive functioning and clinical status according to disease severity.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) The patient must have completed the 78-week treatment period of the double-blind CL-758010 study. 2) Female patients must be of non-childbearing potential (i.e. surgically sterilized or at least two years post-menopausal). 3) Male subjects who are sexually active must: a. Be proven to be sterile e.g. vasectomy or; b. Use appropriate contraceptive barrier methods, e.g. a condom. For the latter, in the event where the participant cannot reliably use/or is unable to use contraceptive barriers, his partner (if of childbearing potential) should be instructed to use appropriate contraceptive devices or methods to avoid pregnancy. 4) The patient must be living in a community with a reliable caregiver that will be attending each clinic visit, completing required evaluations, supervising and ensuring the administration of all doses of medication during the entire study. A reliable caregiver is an individual who has daily contacts with the patient (e.g. visits and/or phone calls). For consistency, it is recommended to have the same caregiver accompanying the patient at each visit. Patients living in assisted living facilities may be included in the study as long as the study medication intake is supervised and that the patient has a reliable caregiver. Due to the length of this study, it is highly recommended to identify other potential caregivers during the screening evaluation. 5) There must be signed informed consent from the patient or legal representative and the caregiver. 6) The potential participant must be able to perform the required psychometric tests and evaluations. Visual and auditory acuity (with glasses or hearing aid, if required) must be sufficient to complete the protocol-specified measures.
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E.4 | Principal exclusion criteria |
1) The patient has acquired immune deficiency syndrome (AIDS) or is positive for the human immunodeficiency virus (HIV), as revealed through medical history. 2) The patient has an allergy and/or hypersensitivity to any component of the study medication. 3) The patient has a history of drug or alcohol abuse within the previous five years. 4) The patient has a clinically significant and/or uncontrolled medical condition that, in the opinion of the treating physician, would pose a safety risk if the patient continued taking the study medication. 5) The presence of a significant nutritional deficiency, as defined by a Mini Nutritional Assessment (MNA) score of less than 17. 6) The patient has a clinical condition that might interfere with the interpretation of safety results. 7) The patient has a condition that can significantly affect the absorption of the study medication. 8) The patient participates in another trial during the study. 9) The patient is unable to swallow medication tablets. 10) The patient is otherwise unsuitable for this type of trial as determined by the treating physician. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Measures • Adverse event assessments • Clinical laboratory parameters • Vital signs/physical examinations/electrocardiograms
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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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 66 |
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 | Yes |
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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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |