| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
Alzheimer's Disease.
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Enfermedad de Alzheimer. |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 10.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10001896 |
| E.1.2 | Term | <Manually entered code. Term in E.1.1> |
|
| 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 the effect of SSR180711C at the doses of 2, 8 and 20 mg/d for 4 weeks, in comparison to placebo, on cognitive performance in patients with mild AD. |
|
| E.2.2 | Secondary objectives of the trial |
To explore the effect of SSR180711C on global clinical status, functional impairment and behavioral disturbances in patients with mild AD.
To assess the safety/tolerability of SSR180711C in patients with mild AD.
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|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Patients with mild AD.
The diagnosis of AD should be based on:
-DAT DSM-IV criteria
-NINCDS/ADRDA criteria for Probable AD.
• The diagnosis should also be supported by:
-Modified Hachinski score ≤ 4
-MRI performed within 6 months of randomization should not reveal other causes of dementia.
• The mild range of severity should be established by:
-Mini-Mental State Examination score ≥ 20 and ≤ 26 at screening. The score should be ≥ 19 and ≤ 27 at baseline.
-Clinical Dementia Rating : 0.5 or 1 at screening.
|
|
| E.4 | Principal exclusion criteria |
• Medical condition, which may interfere with the study conduct and/or assessment:
-Age < 55 years or >90 years.
-Females of childbearing potential. Females of child bearing potential are defined as females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral oopherectomy) or are not postmenopausal (amenorrhea for 12 consecutive months or women on hormone replacement therapy [HRT] with documented follicle stimulating hormone [FSH] levels of 35 mlIU/mL or more).
-Severe or unstable cardiovascular, respiratory, renal, hepatic, hematological, endocrinological, neurological or other somatic disease evidenced by history, or physical examination, which may interfere with the study in the investigator’s judgment (through interference with the evaluation of the study drug or with the absorption, metabolism or excretion of the study medication).
-History of epileptic seizures other than simple childhood febrile seizures.
-Alteration on screening laboratory tests or ECG revealing diseases which may interfere with the study in the investigator’s judgment, and/or QTcF>500 ms.
-Evidence of psychiatric condition, which may interfere with the study in the investigator’s judgment.
-Current symptoms of depression at screening defined by a score on the Hamilton Depression Rating Scale (17-item HAM-D) above 13.
-Lens opacity in either eye at the pre-treatment slit lamp examination, as defined by one of the following criteria:
*Nuclear opalescence ≥ 4 LOCS III grade
*Cortical lens opacities ≥ 3 LOCS III grade
*Posterior subcapsular lens opacities ≥ 2 LOCS III grade
*Cataract surgery scheduled or anticipated in the following 2 months
Patients should also be excluded in case of
*Inability to grade nuclear, cortical, or posterior subcapsular opacities in either eye with LOCS III at the baseline slit lamp examination
*Eye disorder likely to require treatment in the following 2 months and/or interfering with the eye examination
*Vision or hearing disturbances which may interfere with testing procedures, or inability to perform appropriately the CDR-S test, in the opinion of the administrator supervising the screening session
• Treatments, which may interfere with the study conduct and/or assessment:
-Concomitant or previous treatment with acetylcholinesterase inhibitors and/or memantine (i.e patients will be “naïve” with respect to these treatments).
-Treatment with antipsychotics, tricyclic and MAOI antidepressants, or anxiolytics and hypnotics. If previously administered, the patient should have stopped taking these drugs at least 4 weeks prior to randomization.
-Participation in another clinical trial with an investigational drug within two months prior to randomization.
• Related to consent and patient’s environment
-Inpatient, or patient living in a living care facility
-Lack of reliable caregiver, who has at least four hours of contact per day with the subject for at least four days per week or alternatively, 2 hours of contact with the subject seven days per week.
-Refusal or inability to give informed consent to participate in the study: patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) must give their informed written consent and are capable of following study procedures.
• Related to donepezil
-Hypersensitivity to donepezil hydrochloride or to piperidine derivative.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Cognitive performance, evaluated by the Cognitive Drug Research computerized assessement system (CDR-S). |
|
| 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 | 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) | 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
| 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 | 16 |
| 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 |
|
| 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
| |
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | 15 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
| E.8.9.2 | In all countries concerned by the trial days | 15 |
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