Are anti-dementia drugs useful in advanced dementia?

Phase 4

• Conditions: Advanced dementia; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN12134230
• Lead Sponsor: Gerencia de Atención Primaria of Mallorca

Brief Summary

2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30971215 (added 21/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Last Update Posted: 9 September 2019
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 251

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified