Project DEMEN-COMPLIANCE

Real-world assessment of caregiver preference and satisfaction as well as treatment compliance with twice-weekly versus daily rivastigmine patches

At present, no cure for AD is available. Current treatments manage to slow down the progression of symptoms or delay institutionalization  of  the  patient. Cholinesterase inhibitors (AChEI) are the most frequently prescribed drugs to address mild to moderate AD manifestations. Currently,   three  ChEIs  are  commonly  used  to  treat  AD  patients:  donepezil, rivastigmine and galantamine. Of these, rivastigmine is the only medication available as the trandermal patch in Europe.

Adherence is critical in patients with AD in order to achieve optimal benefit from therapy and improve or maintain quality of life. However, patient compliance with the treatment remains a challenge. Indeed, lack of adherence to drug treatment is a major problem in older people with often multiple and chronic diseases, as is the case  with  AD.   Memory   problems and  other  cognitive  deficits  associated  with dementia make patients with AD especially susceptible to therapeutic noncompliance. Medication adherence in these patients is also affected by several other factors that are common in elderly people, such as physical impairments, polymedication and an increased risk of drug interactions and sensitivity to adverse effects.

As the dementia progresses, patients require increasing levels of care and most   people with AD need help managing their medication. In this sense, caregivers, especially family members, are often responsible for administering and managing medications and play a key role in the care and treatment compliance of patients with AD. In fact, medication management contributes to the burden associated with caring for patients with AD.

This responsibility is often a cause for concern, especially when side effects associated with medications occur or there are concurrent illnesses involving other drug administration schedules. In addition, having time to administer treatment can also be a source of stress for caregivers who have other commitments, such as work. Thus, the choice of treatments among the available options is likely to be influenced by the preference of the caregiver, who will tend to choose easier to use modes of drug administration. This could decrease caregiver stress, favoring patient health and  compliance. Understanding caregivers’ treatment preferences and the reasons for those preferences can help maximize the effectiveness of the intervention.

Rivastigmine is approved for the symptomatic treatment of mild to moderate AD and is available as a transdermal patch formulation, the efficacy and safety of which has been demonstrated in several randomized controlled trials. Rivastigmine patches can be administered once daily or twice-weekly.¹⁸ Study results have suggested that treatment with the rivastigmine transdermal patch may improve adherence and compliance, which could lead to increased treatment benefits for patients with dementia of Alzheimer’s type. Additionally, it should be associated with a need for  less  planning  and logistics of  thepatients  and caregivers and thus less burden on the caregiver. Patient and caregiver satisfaction is essential for good adherence to treatment.

Patients selection and study design

A multicenter, prospective, observational, non-interventional study of 24 weeks duration will be carried out with AD patients who have been switched to twice-weekly  transdermal  rivastigmine patch  from  daily  transdermal  rivastigmine patch. Eligible participants will be patients diagnosed with mild or moderate AD, with a Global Deterioration Scale score of 3, 4 or 5. In addition, eligible participants will be patients who had been treated with daily rivastigmine transdermal patch for a minimum period of 6 months prior to switching to twice weekly rivastigmine patches.

The study drugs will have been prescribed by the physician in accordance with the marketing authorization and as part of the patients’ routine medical care and prior to study participation. No interventional procedures other than usual care will be performed. Patients will be excluded if contraindicated as per the local prescribing information/summary of product characteristics.

The study will be conducted according to the definition of non-interventional trials. According to this definition, the study drugs were prescribed according to the marketing authorization, and the treatment decision was made as part of the patients’ routine medical care and prior to study participation. Patient assignment to therapy was decided within current practice and medical indication and was clearly separated from the decision to include the patient in the study.

No diagnostic procedures or follow-up will be performed in addition to routine and usual care. Patient treatment, visits and evaluations will be independent of this study, and will be at the discretion of the treating physician following local standard medical practice and local prescribing information.

 

Variables and measurements

Primary objectives

The primary end points of the study will be assessed using a modified versión of the Alzheimer’s  Disease Caregiver Preference Questionnaire (ADCPQ).

Caregiver preference for twice-weekly rivastigmine patch or daily rivastigmine patch will be evaluated at weeks 12 and 24.

Caregiver satisfaction with daily rivastigmine patch will be assessed at study entry. Caregiver satisfaction with twice-weekly rivastigmine patch will be assessed at week 12 and 24.

The patient´s compliance with daily rivastigmine patch will be assessed at study entry. The patient´s compliance with twice-weekly rivastigmine patch will be assessed at week 12 and 24.

 

Secondary objectives

Caregiver burden will be assessed by means of the Zarit Caregiver Burden Interview (CBI) at study entry and week 24.

 

Additional assessments

Perceived improvement will be assessed by caregivers and researchers using  the  Clinical  Global  Impression  of  Change  scale (CGI-C)  at  week  24.

Cognitive functioning  will be evaluated by means of the Mean Mini-Mental State Examination (MMSE) at study entry and week 24.