Efficacy and safety of S 38093 versus placebo in patients with mild to moderate Alzheimer's disease

Phase 2

Completed

• Conditions: Mild to moderate Alzheimer's disease; Mental and Behavioural Disorders; Alzheimer's disease

• Registration Number: ISRCTN89039808
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-28
• Study Completion: 2014-04-30
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 711

Inclusion Criteria

1. Age 55-85 years
2. School education more than or equal to 4 years
3. Able to perform neuropsychological tests
4. Have adequate visual and auditory acuity with the usual corrective aids to allow neuropsychological testing
5. Have a responsible informant Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for Dementia of the Alzheimer's type
6. National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease (AD)
7. Mini-Mental State Examination (MMSE) between 15 and 24

Exclusion Criteria

1. Inpatients
2. Female patients of child-bearing potential
3. Dementia due to any condition other than AD
4. History of epilepsy or solitary seizure
5. History or presence of Parkinson's disease or Parkinsonism
6. Major neurological or neurodegenerative conditions associated with significant cognitive impairment such as Multiple Sclerosis or Huntington's Disease
7. Major psychiatric conditions

Study & Design

• Study Type: Interventional
• Study Design: Not specified