Evaluation of Anticholinergic Load
1 other identifier
observational
50
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 8, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedDecember 9, 2019
July 1, 2019
5 months
July 8, 2019
December 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 day
Eligibility Criteria
Parkinson's patient
You may qualify if:
- Parkinson's disease
You may not qualify if:
- age \< 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH Montpellier
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
FAURE DELINGER, DOCTOR
UH MONTPELLIER
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2019
First Posted
August 9, 2019
Study Start
June 1, 2019
Primary Completion
November 1, 2019
Study Completion
November 30, 2019
Last Updated
December 9, 2019
Record last verified: 2019-07