An observational study in Cognitive Impairment, Postoperative Delirium and Spine Fusion, sponsored by University Medicine Greifswald. Terminated at 1 site in Germany. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-27.
Sponsored by University Medicine Greifswald · Observational
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Among 102 studies in Cognitive Dysfunction with a site in Germany — 20 open to participants now, 27 under way, 5 of them phase 3. Cognitive Dysfunction · Germany.
Among the 102 studies in Cognitive Dysfunction with a site in Germany, this one is the 14th largest by enrollment of the 27 observational ones that give a count, is one of 9 that started in 2018, is one of 27 observational ones, and was the 49th registered.
3,875 studies on the registry are indexed under Cognitive Dysfunction; 1,121 are open to participants now.
Browse Cognitive Dysfunction studies →20 of the 102 studies in Cognitive Dysfunction with a site in Germany are open now. Recruiting first, the newest first:
Max Planck Institute for Human Cognitive and Brain Sciences · Sites in Germany
Ages 35–60 · Women only · Healthy volunteers
Henrik Bo Wiberg Larsson · Sites in Germany, Denmark
Ages 50–80 · Healthy volunteers
University Hospital, Bonn · Sites in Germany
Ages 50–80 · Healthy volunteers
University Medicine Greifswald · Sites in Germany
Ages 55–75 · Healthy volunteers
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 70+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 751 Cognitive Dysfunction studies recruiting now, 363 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
102 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 18 · Phase 4 4
First in 2004; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 124 is below the median of 150 across 998 observational studies indexed under Cognitive Dysfunction.
Median enrollment 100 across the 75 interventional studies, 124 across the 27 observational. Of the 58 that completed or were terminated, 13 (22%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 102 have an industry lead sponsor. The 10 most frequent:
University Medicine Greifswald is the lead sponsor of 152 studies on the registry; 22 are open to participants now.
University Medicine Greifswald has 6 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
6 of the studies in Cognitive Dysfunction with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06207942Region SkaneStepcare Extended Follow-up Substudy | 2027-01 |
| NCT07114458Universitätsklinikum Hamburg-EppendorfDelirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions | 2027-04 |
| NCT06652828University of OldenburgPerturbation-Based Treadmill Training to Prevent Unrecovered Falls in Geriatric Patients | 2027-04-30 |
| NCT07504965Ludwig-Maximilians - University of MunichDementia-friendly Apothecaries as a Resource for Mental Heath in the Elderly | 2027-07-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 102 studies in Cognitive Dysfunction with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades.
It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.
All patients seen in a neurosurgical oupatient clinic will be screened for eligibility.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
postoperative delirium - incidence
screening through Nu-DESC (Nursing Delirium Screening Scale) ≥ 2 and verification of screening procedure by DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) criteria once during each shift
Time frame: ≤ 3 days postoperatively
postoperative delirium - duration
screening through Nu-DESC ≥ 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift
Time frame: ≤ 3 days postoperatively or until delirium resolves
postoperative delirium - severity
rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious
Time frame: ≤ 3 days postoperatively or until delirium resolves
postoperative cognitive dysfunction - severity
CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus)
Time frame: baseline and 3 months postoperatively
pre- and postoperative intelligence
MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B)
Time frame: baseline and 3 months postoperatively
Markers of systemic inflammation
C-reactive protein, Interleukins, Tumor necrosis factor among others
Time frame: ≤ 2 days postoperatively
Markers of neuroinflammation
Glial fibrillary acidic protein among others
Time frame: ≤ 2 days postoperatively
Markers of oxidative and metabolic stress
Malondialdehyd
Time frame: ≤ 2 days postoperatively
Patient Reported Quality of life
PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating)
Time frame: baseline and 3 months postoperatively
Patient Reported Quality of life - 2
SF-36 (Short Form 36)
Time frame: baseline and 3 months postoperatively
Anxiety and depression
HADS (Hospital Anxiety and Depression Scale)
Time frame: baseline and 3 months postoperatively
Frailty
Groningen Frailty Scale
Time frame: baseline and 3 months postoperatively
Structural magnetic resonance imaging
White matter lesions
Time frame: baseline and 3 months postoperatively
Functional magnetic resonance imaging
Resting state networks
Time frame: baseline and 3 months postoperatively
Cerebral vasculature
Ultrasound of extra- and intracranial cerebral arteries
Time frame: baseline
Genetic polymorphisms
Time frame: baseline
Ran from Feb 2018 to primary completion in Mar 2020, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University Medicine Greifswald →