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 - InvestigationsTherapeutic 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
-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
-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
Name Time Method
- Secondary Outcome Measures
Name Time Method