Investigating the neuroprotective effect of Donepezil in patients affected by Alzheimer disease: a 12 month longitudinal analysis of the peripheral levels of neurotrophins and inflammatory factors in first-diagnosis patients - Donepezil effects on neurotrophins and cytokines

• Conditions: Alzheimer`s Disease; MedDRA version: 12.1Level: LLTClassification code 10001896Term: Alzheimer's disease

• Registration Number: EUCTR2009-017317-30-IT
• Lead Sponsor: FONDAZIONE SANTA LUCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-23
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) AD diagnosis, according to the criteria of DSM-IV and NINCDS-ADRDA; 2) MMSE score < 26 and >16; 3) To be in health and to walk independently or with the aid of a support; 4) Vision and hearing sufficient for compliance with testing procedures; 5) Laboratory values within the appropriate reference intervals or considered to be clinically insignificant by the investigators
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

1) Lack of an appropriate caregiver; 2) Major medical illnesses; 3) Comorbidity of primary psychiatric or neurological disorders; 4) Evidence of focal parenchymal abnormalities at CT or MRI (AD-vascular dementia mixed forms might be included only if the vascular component doesn`t dominate the clinical picture or if a stroke is not present); Hachinski Ischemic Score≤ 4.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified