E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male patients with mild to moderate Alzheimer´ Disease |
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MedDRA Classification |
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 assess in male patients with mild to moderate Alzheimer’ Disease (AD) the potential of ozarelix to improve cognitive function as measured by Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and the Bayer Activities daily Living scale (B-ADL). |
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E.2.2 | Secondary objectives of the trial |
1. To assess the potential of ozarelix to slow the progression of AD. 2. To assess the impact of ozarelix on neurological and cognitive functions as assessed by different scales including Clinical Dementia rating and MMSE. 3. To assess the safety of the test drug.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male patient. 2. 55 years of age or older. 3. Diagnosis of probable AD, mild to moderate according to the NINCDS-ADRDA criteria, at least 6 months prior to screening. 4. Ongoing treatment with cholinesterase inhibitor and/or Memantine®, for 6 months or more and a stable dose at least for the last 3 months. 5. Mini Mental State Examination (MMSE) score of 17 to 26 (inclusive) at the screening visit. 6. Montgomery Asperg Depression Rating Scale (MADRS) score of 19 or less at the screening visit. 7. Available brain imaging study (CT scan, MRI or PET), at screening not older than one year; demonstrating absence of clinically significant lesion. 8. Adequate visual and auditory acuity to complete baseline assessments. |
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E.4 | Principal exclusion criteria |
1. History of a systemic hypersensitivity reaction to drug or any of the excipients. 2. Evidence of significant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other systemic disease or organ failure. 3. Chronic or clinically relevant acute infections. 4. Clinically relevant ECG abnormalities. 5. Clinically relevant abnormalities in clinical chemical, hematological or other laboratory parameters. 6. Abuse of alcohol and drugs. 7. Exposure to another investigational agent within the last month. 8. Significant neurological disease affecting the brain or psychiatric disease other than AD, such as major depression, schizophrenia, epilepsy, Parkinson's Disease, or stroke. 9. MADRS score of 19 or higher. 10. Recent – within last 60 days – or ongoing treatment with testosterone. 11. Recent – within last 90 days – or ongoing use of other medications known to affect serum gonadotropin concentrations, such as danazol or GnRH agonists like goserelin. 12. Recent - within last 60 days – change in the dosage of any drug that affects cognitive function, such as neuroleptics, antidepressants, anxiolytics, sedatives, hypnotics, anti-convulsants, centrally acting antihypertensive agents (clonidine and Aldomet) or other medications such as Vitamin E, nonsteroidal anti-inflammatory drugs, and statins. 13. Ongoing treatment with warfarin or anti-Parkinsonian medications.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. cognitive: Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) sum score (a > 2.5 point improvement be considered a response to treatment) 2. functional: Bayer Activities of Daily Living scale (B-ADL) (a > 0.5 point improvement in the individual mean value will be considered a response to treatment)
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 visit of last patient |
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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 | 0 |
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 | 0 |