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Clinical Trials/EUCTR2016-003451-30-ES
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.

Registry
who.int
Start Date
December 9, 2016
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

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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