Dopaminergic therapy for Alzheimer's disease patients

Phase 1

• Conditions: Alzheimer's disease; MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-002965-43-IT
• Lead Sponsor: I.R.C.C.S. FONDAZIONE S.LUCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

All AD patients will have to show a moderate level of dementia, as assessed by a neuropsychological evaluation including the MMSE (ranging from 18 to 24) and a standardized neuropsychological battery (Carlesimo et al,1996) according to criteria NINCDS-ADRDA
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Subjects with CSF values of Aß1-42 >550 pg/mL will not be included. Subjects will be excluded if they have either two or more hyperintense lesions with a diameter = 10mm or more than eight hyperintense lesions with a diameter between 5 and 9 mm on dual-echo MR images

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to verify the potential clinical impact of dopaminergic agonists on cognitive functions in patients with mild AD.;Secondary Objective: to test if rotigotine change brain physiology. We will use multimodal neurophysiological tools such as transcranial magnetic stimulation combined with electroencephalography (TMS/EEG) to measure changes in cortical reactivity in the prefrontal cortex ;Primary end point(s): Positive effects on general cognitive functions and more specifically on frontal executive functions;Timepoint(s) of evaluation of this end point: 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Increase of prefrontal cortex activity;Timepoint(s) of evaluation of this end point: 2 years