Neurocognitive DisordersVIKINGNCT03276377
VItamin K Inhibition and NeurocoGnition (VIKING)
An observational study of Neurocognitive Disorders, run by University Hospital, Angers at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Neurocognitive Disorders
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2017to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients are recruited in the memory clinic and geriatric day hospital of the University Hospital of Angers, France
Who may be able to join
- Age 70 years and over
- To be seen in consultation or day hospital in the department of geriatrics from 01/01/2015 to 31/12/2016
- Exposed :
- Patients who have been taking VKA for at least 3 months for atrial fibrillation or pulmonary embolism, with INR between 2 and 3
- Non-exposed:
- Patients who have been taking DOAC for at least 3 months for atrial fibrillation or pulmonary embolism
- Matched on age (± 5 years), gender and indication for anticoagulation
Who cannot join
- Severe kidney failure (creatinine clearance < 30 mL/min)
- Language other than French
Trial locations and contacts
1 site in 1 country.
France1 site
Angers University Hospital
Angers, 49933
Cedric ANNWEILER, MD, PhD, ++33 2 41 35 54 86, cedric.annweiler@chu-angers.fr
Antoine BRANGIER, MD, BS
About this study
Official title: Use of Vitamin K Antagonist and Neurocognitive Disorders in Older Adults : a Retrospective Study With Exposed and Non-exposed Groups
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:
- to determine whether patients usually taking VKAs are more likely to have moderate to severe cognitive disorders than matched controls taking DOACs.
- to determine whether VKAs intake is associated with poorer executive functions.
- to determine on CT scans whether the VKAs intake is associated with a greater volume of vascular calcifications in the brain compared to the use of DOACs.
Read the detailed description
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.
- Conditions
- Neurocognitive Disorders
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed to VKA | VKA intake Patients who have been taking VKA for at least 3 months | |
| Non-exposed to VKA | DOAC intake Patients who have been taking DOAC for at least 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276377
- Sponsor's protocol ID
- 2017/19
- Acronym
- VIKING
- Status last verified
- Aug 2017
- First submitted
- 4 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Vitamin K Antagonist and Neurocognitive Disorders in Older Adults : a Retrospective Study With Exposed and Non-exposed Groups
- ClinicalTrials.gov ID
- NCT03276377
- Acronym / sponsor ID
- VIKING / 2017/19
- Conditions
- Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to determine whether patients usually taking VKAs are more likely to have moderate to severe cognitive disorders than matched controls taking DOACs.
- to determine whether VKAs intake is associated with poorer executive functions.
- to determine on CT scans whether the VKAs intake is associated with a greater volume of vascular calcifications in the brain compared to the use of DOACs.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed to VKA | – | –VKA intake Patients who have been taking VKA for at least 3 months |
| Non-exposed to VKA | – | –DOAC intake Patients who have been taking DOAC for at least 3 months |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients are recruited in the memory clinic and geriatric day hospital of the University Hospital of Angers, France
Key inclusion criteria (7 listed)
- Age 70 years and over
- To be seen in consultation or day hospital in the department of geriatrics from 01/01/2015 to 31/12/2016
- Exposed :
- Non-exposed:
Key exclusion criteria (2 listed)
- Severe kidney failure (creatinine clearance < 30 mL/min)
- Language other than French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the global cognitive performance between geriatric patients exposed and non-exposed to VKA
Time frame: Baseline
Global cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score
3 secondary outcomes
Comparison of moderate-to-severe dementia diagnosis between geriatric patients exposed and non-exposed to VKA
Time frame: Baseline
Comparison of the executive functions between geriatric patients exposed and non-exposed to VKA
Time frame: Baseline
Evaluation of the volume of vascular calcifications in the brain according to the use of VKAs
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cedric ANNWEILER, MD, PhD (++33 2 41 35 54 86, cedric.annweiler@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the global cognitive performance between geriatric patients exposed and non-exposed to VKA (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.