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 efficacy of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months versus matched placebo |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months versus matched placebo.
To evaluate the pharmacokinetic profile of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women (non-childbearing potential) with a diagnosis of Alzheimer’s disease according to the NINCDS-ADRDA clinical criteria. 2. Age 60 - 85 years inclusive. 3. MRI or CT assessment within 12 months before baseline corroborating the clinical diagnosis and excluding other potential causes of dementia, especially cerebrovascular lesions (see exclusion criteria, number 3). 4. Mild to moderate stage of Alzheimer’s disease according to MMSE 15-26 inclusive. 5. Geriatric Depression Scale below or equal 7. 6. caregiver is available and is living in the same household, or interacts with the patient at least 4 times a week. 7. Patients living at home or old people’s home without continuous nursing care. 8. If anticholinesterase treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2). 9. If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2). 10. If SSRI or MAOI treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2). 11. No regular intake of medications acting on central nervous system or any anti-inflammatory agents.
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E.4 | Principal exclusion criteria |
1. Hospitalization or change of chronic concomitant medication 1 month prior to screening or during screening period. 2. Clinical, laboratory or neuroimaging findings consistent with: • other primary degenerative dementia, (dementia with Lewy bodies, frontotemporal dementia, Huntington’s disease, Jacob-Creutzfeld Disease, Down’s syndrome, etc) • other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.) • cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter) • other central nervous system diseases (severe head trauma, tumors, subdural haematoma or other space occupying processes, etc.) • seizure disorder • other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.) 3. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder. 4. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as: • hepatic or respiratory insufficiency •renal insufficiency (serum creatinine >2mg/dl) • heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening) • bradycardia (heart beat <50/min.) or tachycardia (heart beat >95/min.) • hypertension or hypotension requiring treatment with more than 3 drugs • AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males >450 and females >470 msec) • uncontrolled diabetes • malignant tumors within the last 5 years except skin malignancies (other than melanoma) or indolent prostate cancer • metastases 5. Women who are fertile and of child bearing potential. 6. Chronic daily drug intake of: • antidepressants, benzodiazepines, neuroleptics or major sedatives • antiepileptics • anticholinergics • nootropics (including Gingko) • centrally active anti-hypertensive drugs (clonidine, alpha-methyl dopa, guanidine, guanfacine, …) • opioid containing analgesics • non steroid anti-inflammatory agents, cortico-steroids or immunosuppressants 7. Suspected or known allergy to any components of the study treatments. Known allergies, including allergy to the study drug or its constituents or known cholinomimetic hyperreactivity 8. Enrollment in another investigational study or intake of investigational drug within the previous 3 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the efficacy of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months versus matched placebo based on the following end-point: Cognitive Drug Research (CDR) battery (computer based cognitive testing battery - composite scores of Power of Attention and Quality of Episodic Memory
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | 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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
6 months double-blind followed by 6 months open-label |
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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 | 12 |
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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |