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Molecular imaging for the early diagnosis and monitoring of Alzheimer’s disease in old individuals with cognitive disturbances

Conditions
Mild Congitive Impairment (MCI)
MedDRA version: 14.1Level: LLTClassification code 10050727Term: RI scanSystem Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Registration Number
EUCTR2011-004415-24-IT
Lead Sponsor
IRCCS CENTRO SAN GIOVANNI DI DIO
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

-Male and female aged between 55-90 years; -Memory complains reflecting a change in cognition reported by patient or informant or clinician; -Presence of objective memory or other cognitive domain impairment; -General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease cannot be made by the site physician at the time of the screening visit; -Mini-Mental State Exam score between 24 and 30 (inclusive); -Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5; -Amnestic Mild Cognitive Impairment (MCI) (pure amnestic or multidomain); -At least 5 grades education. -Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

-Visual and auditory acuity inadequate for neuropsychological testing; -History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment; -The chronic use of anti-inflammatory drugs -Female subjects of child-bearing potential with a positive pregnancy test; -Female subjects who are nursing;

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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