Assessment of association efficacy of colinergic precursor and cholinesterasic inhibitor somministered transdermal in patient with Alzheimer`s disease and severe behavioural disturbances - ASCOTALCO

• Conditions: patient with Alzheimer disease; MedDRA version: 12.1Level: LLTClassification code 10012295Term: Dementia of the Alzheimer's type, with delusions

• Registration Number: EUCTR2009-016955-23-IT
• Lead Sponsor: AZIENDA USL 2 DI LUCCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-14
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

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

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

- Mini-Mental State Examination pc<14 or pc>26 - not controlled hearth, kidney or liver diseases - not controlled distyroidism - active oncologic diseases

Study & Design

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