EUCTR2016-003451-30-ES
Active, not recruiting
Phase 1
Subjects with subjective cognitive decline: 18F-Florbetaben Positrón Emission Tomography Study. - Euro-SCD-FBB2
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)0 sites30 target enrollmentDecember 9, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Subjects with subjective cognitive decline.
- Sponsor
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. According to the principal investigator, participants must be committed to participate and complete all study procedures.
- •2\. The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
- •3\. Age \>/\= 60\*.
- •4\. MMSE cutoff for inclusion will be \= 26\.
- •5\. CDR\<0\.5\.
- •6\. Has signed the Informed Consent Form voluntarily to participate in the study.
- •\* Women of childbearing potential must agree to sexual abstinence, barrier or hormonal contraceptive methods during the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Subjects those are not able to complete the study.
- •2\. Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT \= 5 x ULN) or advanced renal insufficiency (creatinine \= 2 x ULN).
- •3\. Current or previous history of alcohol abuse or epilepsy.
- •4\. Allergic to Florbetaben or any of its constituents.
- •5\. Multiple drug allergies and/or previous history of contrast allergy.
- •6\. Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function).
- •7\. Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure.
- •8\. Pregnancy or breast feeding or planned pregnancy during the study period.
Outcomes
Primary Outcomes
Not specified
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