DSC-MRP in cognitive decline

• Conditions: Patients with dementing disorders, namely minor alzheimers disease or subjects with mild cognitive impairment and normal controls; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-001583-29-DE
• Lead Sponsor: niversity Hospital Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-12
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Adult subjects, age >45 years
2.Subjects with symptoms of MCI or minor AD referred for diagnostic work-up with MRI -
or mentally healtyh control subjects in the same age range.
3.Willing to undergo all study procedures
4.Subjects who have completed a neuropsychologic assessment or a MMSE with a score that allows full understanding of the study procedures and ability to give informed consent – for control subjects a normal MMSE is required.
5.Subject has voluntarily given written informed consent

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 50

Exclusion Criteria

1. 1.Having any physical or mental status that interferes with the informed consent procedure including self-signed consent
2.Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
3.GFR <60ml/m²/1.73m² (MDRD) as determined from a serum creatinine value not older than 1 week before MR contrast media injection, or subjects on hemodialysis
4.Renal or liver transplant subjects, including subjects with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF)
5.MR contraindications (pacemaker, magnetic clips, severe claustrophobia)
6.Known allergy to Gadobutrol
7.Subjects presenting with a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast medias
8.Having received any investigational drug within 7 days prior to entering this study.
9.Not being able to remain lying down for at least 30-45min (e.g. subjects with unstable angina, dyspnea at rest, severe pain at rest, severe back pain)
10.Close affiliation with the investigational site; e.g. a close relative of the investigator or staff members of the coordinating investigators department.
11.Having been previously enrolled in this clinical trial.
12.Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of the investigational contrast media. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified