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EFFECT OF MEMANTINE TREATMENT ON BRAIN FUNCTION AND MORPHOLOGICAL STRUCTURE IN PATIENTS WITH MODERATE TO SEVERE PATIENTS WITH ALZHEIMER S DISEASE A STRUCTURAL MR AND FMRI STUDY - ND

EFFECT OF MEMANTINE TREATMENT ON BRAIN FUNCTION AND MORPHOLOGICAL STRUCTURE IN PATIENTS WITH MODERATE TO SEVERE PATIENTS WITH ALZHEIMER S DISEASE A STRUCTURAL MR AND FMRI STUDY - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005859-18-IT
Enrollment
Unknown
Registered
2006-11-10
Start date
2006-06-13
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

Moderate to severe Alzheimer s disease MedDRA version: 8.1 Level: LLT Classification code 10009843 Term: Cognitive deterioration

Interventions

Trade Name: EBIXA*56CPR RIV 10MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Memantine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharma

Sponsors

FONDAZIONE SANTA LUCIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - age at baseline at least 50 years; - MRI or TC tomography computerized done within 12 months before the recruitment in agree with the NINCDS-ADRDA criteria for probable AD; - AD patients with a MMSE score equal or higher than 10. - Moderate AD subjects in stable therapy with anticholinesterase inhibitors for at least 3 months; - drugs permitted at stable doses for at least 2 weeks before the recruitment antidepressive, anti-inflammatory, antiipertensive, antipsichotics atypical, vitamine E 1200 mg/day , anticoagulants, blue pills, diuretics, ipnotics. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: - patients with B12 or folic acid clinically significative deficits; - patients with other diseases at time of baseline or not pharmacological corrected such as pulmonary, gastrointestinal, nephritic, cardiovascular; - patients with other psychiatric or central nervous system diseases, in excess of those ones necessary to diagnose probable AD; - patients with a score at Hachinski modified scale more than 4 Rosen WG, et al. 1980 .

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the effect of Memantine drug treatment on brain structure and function in moderate to severe Alzheimer s disease patients;Secondary Objective: To study the effect of Memantine drug treatment throuth the improvement in clinical and neuropsychological assessment;Primary end point(s): Cognitive performance improvement, more precisely a reaction time reduction and greater accuracy of answers in memantine-treated patients—

Countries

Italy

Outcome results

None listed

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