Prospective, open-label, two-arm, parallel-group, single center phase IV clinical trial to evaluate the diagnostic value of a Gadobutrol enhanced dynamic susceptibility perfusion MRI (DSC-MRP) and a non contrast arterial spin labeling perfusion MRI (ASL-MRP) in subjects with minor cognitive impairment or minor Alzheimer's disease compared to age matched mentally healthy subjects.

Phase 4

• Conditions: MCI and minor Alzheimer´s disease (AD); F03; Unspecified dementia

• Registration Number: DRKS00009915
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-14
• Study Start: 2016-01-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

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 healthy 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;

Exclusion Criteria

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the robustness of Gadobutrol enhanced DSC-MRP with ASL-MRP in subjects with MCI and minor Alzheimer´s disease (AD);

Secondary Outcome Measures

Name	Time	Method
• To assess regional perfusion abnormalities with dynamic susceptibility weighted (DSC-) MR perfusion in subjects MCI and minor AD with mentally healthy subjects serving as a reference.<br>• To identify areas of reduced perfusion as marker for a dementing disorder.<br>• To compare the technical performance of both DSC-MRP and ASL-MRP in a cohort of subjects with MCI or minor AD – in regard of image quality and image artifacts.<br>• To assess the diagnostic value of Gadobutrol as a contrast media in DSC-MRP in subjects with MCI or minor AD.<br>• To compare the quantitative results of cerebral blood flow measures in both DSC- and ASL-MRP in an intraindividual comparison;