E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with either spontaneous memory complaint with ou without cognitive impairment or with newly diagnosed mild Alzheimer’s disease. |
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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 | 10027175 |
E.1.2 | Term | Memory impairment |
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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 effect of four weeks treatment with EGb761® in comparison to placebo in three groups of elderly : MC, AD and CNE. The primary endpoint will be the change in brain glucose metabolism at M1 versus baseline as measured using 18 FDG-PET. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the effect of nine months treatment with EGb761® on change in cognitive tests in MC and CNE groups. - To evaluate the effect of 18 months of treatment with EGb761® on change in cognitive tests in MC and CNE groups. - To evaluate the effect of 18 months of treatment with EGb761® on change in brain glucose metabolism in the MC and CNE groups - To evaluate the effect of 18 months of treatment with EGb761® on change in brain atrophy in the MC and CNE groups - To evaluate safety.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Enrolled patients will be ≥ 70 years of age, both sex. - All patients must be willing and able to undergo all test procedures including neuroimaging. - All patients must have a referent. - Informed consent signed by the patient or, if necessary by legal representative - Life expectancy more than two years. - Geriatric depression scale (GDS) <15.
Group Specific Inclusion Criteria Cognitively normal elderly (CNE) - Spontaneous memory complaint by patient, - Mini-Mental State Exam score ≥ 28. - Clinical Dementia Rating = 0. - No DSMIV criteria for Dementia.
Memory complaints (MC) : - Spontaneous memory complaint by patient - Mini-Mental State Exam score ≥ 25 - Clinical Dementia Rating 0.5. - No DSMIV criteria for Dementia.
Mild Alzheimer’s Disease (AD): - MMSE between 20 and 28 (inclusive). - Clinical Dementia Rating ≥ 1.0 - DSMIV criteria for Dementia. - NINCDS/ADRDA criteria for probable AD. - Newly diagnosed patients without treatment by Cholinesterase Inhibitors or Memantin
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E.4 | Principal exclusion criteria |
- Contraindication to MRI and/or PET scan: surgical clips or metallic prostheses (i.e., replacement body parts, such as a hip joint) pacemaker or other pieces of metal in the body (shrapnel, metal filings). Claustrophobia. - Known hypersensitivity to Gingko biloba extract. - Participation in another experimental drug trial at the same time or being in an exclusion period. - Is likely to require treatment during the study with drugs that are not permitted by the study protocol. - Forbidden Concomitant medications: - Cholinesterase inhibitors and memantine, - Specific psychoactive medications (e.g., neuroleptics, chronic anxiolytics including meprobamate or sedative hypnotics, Selective serotonin reuptake inhibitor (SSRI), Monoamine oxidase inhibitors (MAOIs) including selective MAOIs. Doses for antidepressants considered as stable for investigator will be permitted. - Drugs acting on cerebral nervous system - Antidiabetes medications - Antioxidants medications. - Medications known to interfere with cognitive evaluations . - Significant neurological disease: Any significant neurological disease, such as Parkinson’s disease, vascular dementia or degenerative dementia other than mild AD, Huntington’s disease, normal pressure hydrocephalus, brain tumour, progressive supra nuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurological defaults or known structural brain abnormalities. - Psychiatric disorders/psychotic features: - Major depression, bipolar disorder within the past 1 year. - History of schizophrenia. - Psychotic features, agitation or behavioural problems within the last 3 months which could lead to difficulty complying with the protocol. - Alcohol and/or drug abuse: History of alcohol or substance abuse or dependence within the past 2 years. - Significant medical illness: Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the change in brain glucose metabolism from M0 to M 1 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | 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 | 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 |
The first four weeks of the study are double-blinded, placebo-controlled, in parallel-groups (EGb761 |
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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
| 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 | 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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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 | 3 |
E.8.9.1 | In the Member State concerned days | |