Alzheimer`s Disease MedDRA version: 12.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Trade Name: ARICEPT
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Donepezil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: ARICEPT
P
Sponsors
FONDAZIONE SANTA LUCIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) AD diagnosis, according to the criteria of DSM-IV and NINCDS-ADRDA; 2) MMSE score 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This protocol will allow to evaluate the effectiveness of Donepezil treatment on the release of circulating neurotrophins and inflammatory parameters that may influence the neuroprotective effect.;Secondary Objective: This study will also investigate the association between treatment resistance and possible disturbances of the neuro-immune network mediated by neurotrophins and pro and anti-inflammatory molecules. This knowledge will provide useful information on the mechanisms of action of Donepezil and possibly on the pathogenesis of Alzheimer disease;Primary end point(s): 1. To investigate whether the treatment with Donepezil alters the peripheral levels (either those released in plasma or those produced by peripheral blood elements) of neurotrophins, particularly Brain-Derived Neurotrophic Factor (BDNF), and inflammatory mediators (such as IL-18 and other pro-inflammatory cytokines); 2. To analyze whether to alterations of serum levels of neurotrophins and cytokines corresponds a therapeutic response to the Donepezil treatment; 3. To verify whether the effects on neurotrophins and inflammatory mediators can represent a new screening method to test the potential neuroprotective properties of new AD medications | — |
Countries
Italy
Outcome results
None listed