An observational study in Neurocognitive Disorders, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by University Hospital, Angers · Observational
Among 43 studies in Neurocognitive Disorders with a site in France — 20 open to participants now, 23 under way, none of them phase 3. Neurocognitive Disorders · France.
Among the 43 studies in Neurocognitive Disorders with a site in France, this one is the 13th largest by planned enrollment of the 19 observational ones that give a count, is one of 4 that started in 2017, is one of 19 observational ones, and was the 4th registered.
274 studies on the registry are indexed under Neurocognitive Disorders; 90 are open to participants now.
Browse Neurocognitive Disorders studies →20 of the 43 studies in Neurocognitive Disorders with a site in France are open now. Recruiting first, the newest first:
KompanionCare SAS · Sites in France
Ages 60+
MapLight Therapeutics · Sites in France, United States, Argentina and 12 more countries
Ages 55–90
University Hospital, Grenoble · Sites in France
Ages 60+
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 60+
Hospices Civils de Lyon · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 60 Neurocognitive Disorders studies recruiting now, 37 (62%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.
This study: 70 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 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 2 · Phase 2 8 · Phase 3 3
First in 2011; this study’s year is marked. 4 started in 2017.
This study's planned enrollment of 100 is below the median of 150 across 96 observational studies indexed under Neurocognitive Disorders.
Median enrollment 58 across the 24 interventional studies, 135 across the 19 observational. Of the 17 that completed or were terminated, 6 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 43 have an industry lead sponsor. The 10 most frequent:
University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
University Hospital, Angers has 3 studies filed under Neurocognitive Disorders — fewer than ten, so there is no comparison to draw.
8 of the studies in Neurocognitive Disorders with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07237009KompanionCare SASEffects of Personalized Digital Reminiscence Therapy on Patients With Neurocognitive Disorders | 2026-12 |
| NCT05586672Etablissement Public de Santé Barthélemy DurandHR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD | 2027-01-31 |
| NCT07468305Centre Hospitalier Universitaire de NiceSENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: a Pilot Study | 2027-02 |
| NCT05129150University Hospital, ToursCognitive Disorders and Brain Pulse | 2027-03 |
| NCT06801171Centre Hospitalier Universitaire de NiceA Mixed Intervention to Improve Resilience for Patient With Neurocognitive Disorders | 2027-05-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 43 studies in Neurocognitive Disorders with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to determine whether patients usually taking Vitamin K Antagonists (VKAs) exhibit a poorer global cognitive performance than control patients (matched on age, gender and indication for anticoagulation) taking direct oral anticoagulants (DOACs).
The secondary objectives are:
VKAs are the most common drugs in the treatment and prophylaxis of thromboembolic events in older adults. Their action is mediated by decrease in the bioavailability of the active form of vitamin K. However, vitamin K participates in brain health and function by regulating the synthesis of sphingolipids, a constituent of the myelin sheath and the neurons membrane, and through the biological activation of vitamin K-dependent proteins (VKDPs) involved in neuron survival. Epidemiological studies have reported a positive association between higher serum vitamin K concentration and better verbal episodic memory performance in older adults, and an inverse association between dietary vitamin K intakes and cognitive complaint/cognitive disorders/behavioral disorders. VKAs, which deplete the active form of vitamin K, may thus be responsible for neurological disorders. CNS abnormalities were observed in newborns exposed in utero to VKA. Similarly, in two cross-sectional studies, the use of VKAs was directly associated with cognitive disorders in older adults, and with a lower volume of gray matter in the hippocampus.
However, the main limitation of these previous studies was that the different associations reported may actually be explained by the thromboembolic pathology justifying the use of VKA such as atrial fibrillation with potential adverse consequences on the brain.
Thus, the use of DOACs could serve as an ideal comparator, as their indications are similar to those of VKAs but which mechanism does not interfere with vitamin K.
The investigators hypothesize that 1) geriatric patients usually taking VKAs may have lower cognitive performance than those usually taking DOACs; 2) there is an association between VKA intake and cognitive performance in geriatric patients, including after adjustment on the indication for anticoagulation; and 3) that geriatric patients usually taking VKAs exhibit brain changes compared to those usually taking DOACs, including greater calcification burden.
Patients are recruited in the memory clinic and geriatric day hospital of the University Hospital of Angers, France
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.
Exposed :
Non-exposed:
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VKA intake Patients who have been taking VKA for at least 3 months
DOAC intake Patients who have been taking DOAC for at least 3 months
Comparison of the global cognitive performance between geriatric patients exposed and non-exposed to VKA
Global cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score
Time frame: Baseline
Comparison of moderate-to-severe dementia diagnosis between geriatric patients exposed and non-exposed to VKA
Moderate-to-severe dementia defined as a MMSE score \< 20 / 30
Time frame: Baseline
Comparison of the executive functions between geriatric patients exposed and non-exposed to VKA
Executive functioning is assessed by the Frontal Assessment Battery (FAB) score
Time frame: Baseline
Evaluation of the volume of vascular calcifications in the brain according to the use of VKAs
Semi-automated measure of the volume of vascular calcifications in the brain based on CT scan
Time frame: Baseline
Start is estimated for Sep 2017; primary completion for Sep 2018, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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