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Effect of Memantine 20 mg (Ebixa) and Donepezil 5 mg (Aricept) on motor cortex plasticity induced by paired associative stimulation using transcranial magnetic stimulation (TMS) in patients suffering from Mild Cognitive Impairment. A phase II monocentric, double-blind, randomised, placebo-controlled, parallel group study. - ND

Effect of Memantine 20 mg (Ebixa) and Donepezil 5 mg (Aricept) on motor cortex plasticity induced by paired associative stimulation using transcranial magnetic stimulation (TMS) in patients suffering from Mild Cognitive Impairment. A phase II monocentric, double-blind, randomised, placebo-controlled, parallel group study. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-014810-87-IT
Enrollment
Unknown
Registered
2011-05-31
Start date
2010-07-22
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: EBIXA Pharmaceutical Form: Capsule, hard INN or Proposed INN: Memantine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the p

Sponsors

INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: MCI male and female patients and healthy elderly male and female volunteers aged between 60 and 80 years 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: - Any non selection criteria that could have appeared since selection, - Use of any non-authorized medication since the selection visit (including psychoactive drugs), - Acute symptoms, signs or disorders appearing since the selection visit, - Surgery since the selection visit.

Design outcomes

Primary

MeasureTime frame
Main Objective: To assess the potential effects of one month of repeated administration of donepezil and memantine compared to placebo on motor cortex plasticity induced by paired associative stimulation using transcranial magnetic stimulation (TMS) in MCI patients;Secondary Objective: - To assess the potential effects of a single administration and one week of repeated administration of donepezil and memantine compared to placebo on motor cortex plasticity induced by paired associative stimulation using transcranial magnetic stimulation (TMS) in MCI patients - To assess the potential effects of donepezil and memantine compared to placebo on performances using a motor task in MCI patients - To compare at baseline motor cortex plasticity induced by paired associative stimulation using transcranial magnetic stimulation (TMS) and performances in motor test in elderly healthy volunteers and MCI patients;Primary end point(s): - Transcranial Magnetic Stimulation (Paired Associative Stimulation) : Motor-Evoked Potential (MEP) amplitude+ (% of baseline*) after 28 days of study drug treatment in MCI patients * baseline = pre-test measurement (T0). T0 refer to the first measurement after the rPAS conditioning protocol. + MEP amplitude is defined as a peak-to-peak MEP amplitude (average of 20 responses).—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026