Evaluation of Anticholinergic Load

• ClinicalTrials.gov Identifier: NCT04051125
• Recruitment Status: Completed
• First Posted: August 9, 2019
• Last Update Posted: December 9, 2019
• Sponsor: University Hospital, Montpellier
• Information provided by (Responsible Party): University Hospital, Montpellier

Study Description

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

Condition or disease
Parkinson Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Anticholinergic Load Using the ACB "Anticholinergic Cognitive Burden" Scale in Parkinson's Patients
• Actual Study Start Date: June 1, 2019
• Actual Primary Completion Date: November 1, 2019
• Actual Study Completion Date: November 30, 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Probability Sample

Study Population

Parkinson's patient

Criteria

Inclusion Criteria:

• Parkinson's disease

Exclusion Criteria:

• age < 18 years

Contacts and Locations

Locations

France

UH Montpellier

Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

• Study Director: FAURE DELINGER, DOCTOR; UH MONTPELLIER

More Information

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04051125
• Other Study ID Numbers: RECHMPL19_0279
• First Posted: August 9, 2019
• Last Update Posted: December 9, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: NC

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases