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Clinical Trials/EUCTR2007-001639-80-ES
EUCTR2007-001639-80-ESActive, not recruitingNot Applicable

A multicenter, double-blind, parallel-group, placebo-controlled study of the effect on cognitive performance and safety/tolerability of SSR180711C, at the doses of 2, 8 and 20 mg/d for 4 weeks, using donepezil as calibrator, in patients with mild Alzheimer's Disease.----------------------------------------------------------------------------------------------------Estudio multicéntrico, con grupos paralelos, doble ciego y controlado con placebo sobre el efecto en la actividad cognitiva y la seguridad/tolerabilidad de SSR180711C, a las dosis de 2, 8 y 20 mg/día durante 4 semanas, utilizando donepezilo como control positivo, en pacientes con Enfermedad de Alzheimer leve

sanofi-aventis recherche & développement0 sites200 target enrollmentStarted: February 14, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
200
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range
  • •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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

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.
  • •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
  • +4 more not shown

Investigators

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