Patients with dementing disorders, namely minor alzheimers disease or subjects with mild cognitive impairment and normal controls
Conditions
Sponsors
University Hospital Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the robustness of Gadobutrol enhanced DSC-MRP with spin-labeling perfusion studies in subjects with MCI and minor Alzheimer´s disease (AD) ;Secondary Objective: • To assess regional perfusion abnormalities with dynamic susceptibility weighted (DSC-) MR perfusion in subjects with symptoms of mental decline with mentally healthy subjects serving as a reference. • To identify areas of reduced perfusion as early marker for a dementing disorder. • To compare the technical performance of both DSC-MRP and ASL-MRP in a cohort of subjects with mental decline – in regard of image quality and image artifacts. • To assess Gadobutrol as a contrast agent in DSC-MRP in patients with MCI or minor AD. • To compare the quantitative results of cerebral blood flow measures in both DSC- and ASL-MRP in an intraindividual comparison. ;Primary end point(s): All images will be evaluated for technical adequacy by on site and off site readers to check their eligibility. A blinded read will be performed off site using appropriate technology and equipment. The preparation of the reading will be adhering to international quality standards and documented accordingly. On site, the MR perfusion source data will be analyzed in a standardized way using the Siemens "MRPerf" software. This software generates color-coded parameter maps of mean transit time (MTT), time to peak (TTP), relative cerebral blood volume (rCBV) and relative cerebral blood flow (rCBF). Furthermore, a global bolus plot (GBP) is calculated, showing the time course of the global T2* signal. CE-MRA will be reconstructed on site as rotating thick slice maximum intensity projections (MIP). The blinded readers will have access to the source data, as well as the MIPs. For both DSC- and ALS-MRP, the visual (qualitative) image analysis in the blinded read will comprise a dedicated simultaneous matched-pairs assessment from both examinations together. The blinded readers will assess the technical adequacy o | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: July 2013;Secondary end point(s): ROI-Analysis To compare the perfusion results both group of patients and normal volunteers will be assessed by a quantitative ROI based analysis. After post-processing of the perfusion data ROIs will be placed in normal appearing white and grey matter on the anatomic images. The ROIs will be relocated to the parameter maps of CBF and CBV and compared accordingly. As in ASL MRP only CBF maps are available the quantitative results will only be compared for CBF. Based on all available measurements we try to identify perfusion as an early marker for the development of an dementing disorder in the group of MCI subjects. For that MCI subjects will be clinically monitored for at least 12 month after inclusion into the study. Technical Assessment – Image Quality - Artifacts The technical performance of the two perfusion techniques will be compared in the qualitative assessment in an intraindividual comparision. For both the raw data of perfusion and the generated parameter maps the image quality will be rated on a four point scale: • Poor • Moderate • Good • Excellent and also as diagnostic or non-diagnostic. DSC-MRP As quantitative DSC-MRP parameters highly depend on the current circulation status of the patient, no quantitative assessment will be performed. | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Arnd Dörfler
University of Erlangen
Outcome results
None listed