E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney. |
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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 | HLT |
E.1.2 | Classification code | 10001897 |
E.1.2 | Term | Alzheimer's disease (incl subtypes) |
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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 safety and tolerability of HF0220 in a patient population.
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E.2.2 | Secondary objectives of the trial |
To validate biochemical markers relevant to Alzheimer's disease as appropriate end-points in a future chronic clinical study of the neuroprotective effect of HF0220 in patients with a diagnosis of mild-to-moderate Alzheimer's Disease. To assess the suitability of chosen dose levels for future studies. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Mild/moderate dementia as evidenced by a screening Mini-Mental State Examination (MMSE) score of 12-24 inclusive
2. Capable of understanding written procedures and giving written informed consent.
3. Male and Female outpatients with Alzheimer’s disease The diagnosis should be established in accordance with the NINCDS-ADRDA classification1 for probable Alzheimer’s disease. Patients living in residential homes for the elderly will be excluded
4. Patients aged over 55 years
5. Patients who live with or have at least daily visits from a responsible carer This includes a friend or relative. The carer should be capable of assisting with the patient’s medication, prepared to attend with the patient for assessment and willing to provide information about the patient. There may be more than one carer, however, the same carer should assess the patient throughout the study, wherever possible. If there is a local requirement, the responsible carer will sign the carer informed consent form confirming they are willing to help the patient during the study and willing to visit with them for each assessment
6. Written informed consent Written consent should be obtained from the patient and responsible carer and countersigned by the responsible physician
7. Depending on the biomarker results from Plan A, a decision will be made whether or not to include a biomarker as an entry criterion for Plan B. If a biomarker inclusion criterion is required, it will only be added after approval as a substantial protocol amendment.
8. A negative screen for drugs of abuse, serum hepatitis B surface antigens, and hepatitis C |
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E.4 | Principal exclusion criteria |
1. Primary, secondary or pseudo- dementias 2. Concomitant medication, such as antipsychotics, anti-Parkinson’s drugs, anticonvulsants, cholinergic agents, NSAIDs, or Over-The-Counter medication other than approved by the Investigator 3. Excessive alcohol intake, malnourishment, use of antioxidant supplements; active smokers 4. Women of child-bearing potential or nursing mothers 5. Patients otherwise unsuitable for this study type, or feeling unable to comply with the restrictions required by the study
(The full list is given in Section 7.3 of the Study Protocol) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Candidate dose level and validation of biochemical markers indicative of HF0220 action. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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.8.4.1 | 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 | 6 |
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 | Information not present in EudraCT |
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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Last post-dose visit 14 days following completion of final dose (i.e., Day 43) |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |