Parkinson DiseaseNCT04051125
Evaluation of Anticholinergic Load
An observational study of Parkinson Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Drugs with anticholinergic properties may cause central and peripheral side effects. Several scales have been developed to evaluate the anticholinergic effect of drugs. Numerous studies have been published, showing a link between the anticholinergic load and the occurrence of adverse effects in the elderly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 30 Nov 2019
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Parkinson's patient
Who may be able to join
- Parkinson's disease
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anticholinergic Load Using the ACB "Anticholinergic Cognitive Burden" Scale in Parkinson's Patients
Drugs with anticholinergic properties may cause central and peripheral side effects. Several scales have been developed to evaluate the anticholinergic effect of drugs. Numerous studies have been published, showing a link between the anticholinergic load and the occurrence of adverse effects in the elderly.
Anticholinergic Cognitive Burden is a scale that identifies the severity of adverse effects of anticholinergic drugs specifically on cognition including cognitive decline, mental confusion, mild cognitive impairment, and dementia. It was developed from reviews of the medical literature and the calculation of drug affinities for muscarinic receptors. This list of drugs was presented to a team of experts including geriatricians, psychogeriatrists geriatric nurses and pharmacists, who assigned these drugs three scores ranging from 1 to 3:
Read more
- score 1: drugs with a possible anticholinergic effect on cognition demonstrated in vitro by its affinity for the muscarinic receptor or by calculation of the ASA level (anticholinergic activity of the serum), but without relevant clinical evidence of cognitive adverse effects;
- scores 2 and 3: drugs whose moderate or severe anticholinergic effect on cognition has been clearly established clinically. The drugs of scores 2 or 3 are differentiated by their ability to cause confusion and their properties to penetrate or not the blood-brain barrier.
The sum of the scores of the different drugs taken by the patient determines the cumulative cognitive risk score related to anticholinergics.
This ACB scale seems to be the most relevant in Parkinsonian patients.
Parkinson's disease (PD) is described for the first time in 1817 by an English doctor who gives it his name.
Parkinson's disease is a chronic, slowly progressive condition defined by the presence of motor symptoms (resting tremor, slowness and difficulty of movement or bradykinesia, muscle rigidity, equilibrium disorders) associated with variable non-motor symptoms ( such as constipation, fatigue, depression and anxiety, sleep disorders, impaired sense of smell, cognitive disorders). Age is the main risk factor for the disease (?).
There is a significant increase in the number of cases due to the aging of the population and the improvement in life expectancy.
By 2030, the number of Parkinson's patients could increase by 56% with 1 in 120 people over 45 with the disease.
Parkinsonian patients are subjected to a higher anticholinergic load, by the therapeutics used in their pathologies (antidepressants, neuroleptics, antiparkinsonians, etc ...).
These central and peripheral anticholinergic effects may add to the symptomatology in Parkinson's patients and aggravate their pathology.
My study project aims to improve the management of elderly patients with Parkinson's disease.
Hypothesis: People involved in the management of Parkinson's patients are not always aware of the potential anticholinergic effects of drugs. Indeed, anticholinergic effects can be responsible for many hospitalizations in the elderly.
This is why we want to make an inventory of treatments in Parkinson's patients at the entrance of hospitalization by evaluating the anticholinergic load using the ACB scale and the hospitalization exit in order to know if this score changed after informing the doctors responsible
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of anticholinergic load
assessing the anticholinergic load using the scale ACB " Anticholinergic Cognitif Burden ". Anticholinergic Cognitive Burden is a scale to identify the severity of adverse effects of anticholinergic drugs specifically on cognition including cognitive decline, mental confusion, mild cognitive impairment, and dementia
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start1 Jun 2019
- Primary completion1 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FAURE DELINGER, DOCTOR, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051125
- Sponsor's protocol ID
- RECHMPL19_0279
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anticholinergic Load Using the ACB "Anticholinergic Cognitive Burden" Scale in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT04051125
- Acronym / sponsor ID
- RECHMPL19_0279
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 9 Aug 2019 (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.
Drugs with anticholinergic properties may cause central and peripheral side effects. Several scales have been developed to evaluate the anticholinergic effect of drugs. Numerous studies have been published, showing a link between the anticholinergic load and the occurrence of adverse effects in the elderly.
Anticholinergic Cognitive Burden is a scale that identifies the severity of adverse effects of anticholinergic drugs specifically on cognition including cognitive decline, mental confusion, mild cognitive impairment, and dementia. It was developed from reviews of the medical literature and the calculation of drug affinities for muscarinic receptors. This list of drugs was presented to a team of experts including geriatricians, psychogeriatrists geriatric nurses and pharmacists, who assigned these drugs three scores ranging from 1 to 3:
- score 1: drugs with a possible anticholinergic effect on cognition demonstrated in vitro by its affinity for the muscarinic receptor or by calculation of the ASA level (anticholinergic activity of the serum), but without relevant clinical evidence of cognitive adverse effects;
- scores 2 and 3: drugs whose moderate or severe anticholinergic effect on cognition has been clearly established clinically. The drugs of scores 2 or 3 are differentiated by their ability to cause confusion and their properties to penetrate or not the blood-brain barrier.
The sum of the scores of the different drugs taken by the patient determines the cumulative cognitive risk score related to anticholinergics.
This ACB scale seems to be the most relevant in Parkinsonian patients.
Parkinson's disease (PD) is described for the first time in 1817 by an English doctor who gives it his name.
Parkinson's disease is a chronic, slowly progressive condition defined by the presence of motor symptoms (resting tremor, slowness and difficulty of movement or bradykinesia, muscle rigidity, equilibrium disorders) associated with variable non-motor symptoms ( such as constipation, fatigue, depression and anxiety, sleep disorders, impaired sense of smell, cognitive disorders). Age is the main risk factor for the disease (?).
There is a significant increase in the number of cases due to the aging of the population and the improvement in life expectancy.
By 2030, the number of Parkinson's patients could increase by 56% with 1 in 120 people over 45 with the disease.
Parkinsonian patients are subjected to a higher anticholinergic load, by the therapeutics used in their pathologies (antidepressants, neuroleptics, antiparkinsonians, etc ...).
These central and peripheral anticholinergic effects may add to the symptomatology in Parkinson's patients and aggravate their pathology.
My study project aims to improve the management of elderly patients with Parkinson's disease.
Hypothesis: People involved in the management of Parkinson's patients are not always aware of the potential anticholinergic effects of drugs. Indeed, anticholinergic effects can be responsible for many hospitalizations in the elderly.
This is why we want to make an inventory of treatments in Parkinson's patients at the entrance of hospitalization by evaluating the anticholinergic load using the ACB scale and the hospitalization exit in order to know if this score changed after informing the doctors responsible
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patient
Key inclusion criteria (1 listed)
- Parkinson's disease
Key exclusion criteria (1 listed)
- age < 18 years
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
Evaluation of anticholinergic load
Time frame: 1 day
assessing the anticholinergic load using the scale ACB " Anticholinergic Cognitif Burden ". Anticholinergic Cognitive Burden is a scale to identify the severity of adverse effects of anticholinergic drugs specifically on cognition including cognitive decline, mental confusion, mild cognitive impairment, and dementia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
FAURE DELINGER, DOCTOR study director
UH MONTPELLIER
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 Parkinson Disease, run by University Hospital, Montpellier 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of anticholinergic load (time frame: 1 day). 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 9 Dec 2019.