NCT04051125

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

December 9, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

July 8, 2019

Last Update Submit

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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • FAURE DELINGER, DOCTOR

    UH MONTPELLIER

    STUDY DIRECTOR

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

Locations