Investigating prescription cascades and adverse drug reactions of dementia drug treatments

Study type
Protocol
Date of Approval
Study reference ID
23_003334
Lay Summary

Dementia is an umbrella term used to describe a group of symptoms that affect a person's cognitive abilities, such as their memory, thinking, and reasoning skills. Dementia can be caused by various diseases, with Alzheimer's disease being the most common cause. There are currently only four drug treatments on the market that are recommended to manage symptoms of mild to severe dementia, specifically Alzheimer's disease. Clinical trials have shown mixed results about how good these drugs are, and they have lots of side effects. Unfortunately, sometimes, doctors treat these side effects as new symptoms/diseases rather than side effects of dementia drugs. This is called a “prescription cascade”. It is important to characterise what dementia treatments and other drugs are given as it will help patients, health care providers, and regulatory authorities help manage the disease to enhance patient benefit and reduce mortality. Real-world data such as medical records can help give us further insight into what dementia treatments are initially given as well as other drugs that are given before and after. This study will describe what new drugs are given after dementia treatment starts and will describe the characteristics of these different groups of patients.

Technical Summary

BACKGROUND

There is no cure for dementia and approved drugs have shown inconclusive effectiveness and numerous side effects. The side effects of dementia drug treatments can sometimes be misinterpreted as new medical conditions and additional drugs are prescribed which leads to unnecessary drug therapy leading to a prescription cascade. Persons living with dementia are more vulnerable to prescribing cascades due to increased multimorbidity. In-depth characterization of those on dementia drugs will give crucial insights into the management of disease to healthcare providers, regulatory authorities and patients.

The aim of this project is to characterize the treatments of patients taking dementia drugs and determine potential prescription cascades.

OBJECTIVES:
1) To characterise demographics, comorbidities and medications prescribed to patients before and after a prescription of dementia medication. 
2) To determine potential prescription cascades using Prescription Sequence Symmetry Analysis (PSSA). 

METHODS:
Data: CPRD GOLD
Participants: All adults registered in CPRD GOLD for at least 1 year and older than 18 with a prescription for dementia drug (Donepezil, rivastigmine, galantamine, memantine).
Descriptive analysis will be used to describe the demographics and clinical characteristics of patients taking dementia treatments and other drug treatments. Prescription sequence symmetry analysis will be used to determine potential prescription cascades.

Health Outcomes to be Measured

The outcomes to be measured for this study are: 

Prescription/use of dementia medications: Acetylcholinesterase inhibitors: Donepezil, rivastigmine, and galantamine, or memantine. Prescription patterns of medications in potential prescription cascades before and after starting dementia medications.

Collaborators

Danielle Newby - Chief Investigator - University of Oxford
Danielle Newby - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of Oxford