patient with Alzheimer disease MedDRA version: 12.1 Level: LLT Classification code 10012295 Term: Dementia of the Alzheimer's type, with delusions
Conditions
Interventions
Trade Name: DELECIT
Pharmaceutical Form: Oral solution
INN or Proposed INN: Choline alfoscerate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical
Sponsors
AZIENDA USL 2 DI LUCCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male / female age > 40 yrs - probable AD according to NINCDS-ADRDA criteria with BPSD e/o cognitive fluctuations e/o extra-pyramidal signs - Mini-Mental State Examination 14-pc-26 - patients never treated with ChEI or under treatment with ChEI no more than 2 yrs and now with rivastigmina patch 9,5 mg 1 patch/once a day for at last 2 months and no more than 12 months - subscription of informed consent 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: - Mini-Mental State Examination pc26 - not controlled hearth, kidney or liver diseases - not controlled distyroidism - active oncologic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of association efficacy of colinergic precursor and cholinesterasic inhibitor somministered transdermal in patient with Alzheimer`s disease and severe behavioural disturbances;Secondary Objective: therpeutic efficacy in reducing care-giver`s burden;Primary end point(s): - dementia progression measured with MMSE - behavioural disturbances assessed with NPI | — |
Countries
Italy
Outcome results
None listed