Advanced dementia Mental and Behavioural Disorders Unspecified dementia
Conditions
Interventions
Randomization
A sequence of random numbers will be generated using the Epidat 3.1 program, and used for allocation to each of the two arms. After verification of patient eligibility, t
(ii) the minimum HR for detection of a significant difference is 2.09
and (iii) the correlation between the studied variables is 0.002. Based on an assumed loss rate of 20% per year, at least 302 patients will be en
Sponsors
Gerencia de Atención Primaria of Mallorca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Potential participants will be identified from the billing records of the Pharmacy of the Health Service of the Balearic Islands and the Neurology Service of the Hospital Son Espases from the previous year. After study onset, the list will be updated every 3 months to identify new candidates. Primary care health centers will be provided with a list of patients receiving treatment with drugs for dementia, and the recruitment will be based on review of their clinical histories. Billing information for 2015 in the Balearic Islands indicated there were 4169 patients over 75 years-old who received treatment with a drug for dementia for 3 months or more. We anticipate we may experience some difficulties in the recruitment due to the fact that the general practitioners participating in this study would be expected to discontinue a drug that was initially prescribed in the hospital setting, mostly by neurologists. This study will include patients with advanced dementia who are living in the community and receiving treatment in a primary care setting or a hospital. Participants must have the following criteria for enrollment: 1. Patient with dementia due to AD, according to National Institute on Aging and Alzheimer’s Association (NIA-AA) criteria, with or without small vessel subcortical vascular disease Fazekas 1 or 2 2. Advanced dementia (MMSE = 10) 3. Use of C in stable dose for 6 months or more 4. Completion of informed consent agreement by the caregiver (and the patient when appropriate) 5. Patients without clinical changes of dementia or acute decompensation of concomitant systemic diseases and stable in their pharmacological treatment for dementia or other diseases in the last 3 months
Exclusion criteria
Exclusion criteria: 1. Patients with non-AD suspected pathology as the main cause of the dementia 2. Life expectancy less than the follow-up duration of the study 3. On a waiting list for interventions or treatments that require hospitalization 4. Participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to institutionalization and/or progression of disability (defined as a loss of 2 of 4 basic functions, or 6 of 11 instrumental functions using the Bristol activities of daily living scale (BADLS)). Data on the time to institutionalization will be collected by interview with the caregiver and/or review of the clinical history. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognitive assessment with SMMSE at baseline, 1, 3, 6 and 12 months (study end) 2. Functional assessment with BADLS at baseline, 1, 3, 6 and 12 months (study end) 3. Functional assessment with Functional Assessment (FAST) scale at baseline and 12 months (study end) 4. Advanced dementia quality of life assessed with Quality of Life in Late-Stage Dementia (QUALID) at baseline, 1, 3, 6 and 12 months (study end) 5. Quality of life related to health assessed with EuroQol five dimension (EQ-5D) scale at baseline and 12 months (study end) 6. Psychological and behavioral symptoms associated with dementia assessed with Neuropsychiatric Inventory-Questionnaire (NPI-Q) at baseline, 1, 3, 6 and 12 months (study end) 7. Caregiver overload assessed with Zarit Scale at baseline, 1, 3, 6 and 12 months (study end) 8. Clinical improvement impression assessed with Clinical Global Impression of Change (CGIC) at 12 months (study end) 9. Use of health resources in dementia assessed with Resource Utilization in Dementia (RUD) Lite scale at 12 months (study end) 10. Safety, adverse effects and mortality assessed with adverse effects forms at 1, 3, 6 and 12 months (study end) | — |
Countries
Spain
Outcome results
None listed