Status:
COMPLETED
Withdrawal of Antidementia Drugs in Advanced Dementia (WADAD)
Lead Sponsor:
Centro Hospitalar De São João, E.P.E.
Conditions:
Dementia
Eligibility:
All Genders
Phase:
NA
Brief Summary
Dementia is a chronic progressive mental disorder that adversely affects higher cortical functions, including cognition and behavior leading up to disability and dependence in daily life activities. I...
Detailed Description
Specific aim 1. Explore the effects of discontinuing ChEI and/or memantine on global impression, disease severity, function, behavior and cognitive outcomes; Hypothesis: 1. Progression to disability...
Eligibility Criteria
Inclusion
- Diagnosis of dementia syndrome defined by clinical criteria (Alzheimer's dementia according to NIA-AA 2011 criteria, vascular dementia or mixed dementia)
- MMSE≤15
- Medicated with oral/transdermal patch anti-dementia (donepezil, rivastigmine, galantamine or memantine), alone or in combination, for a minimum period of 3 months;
- Availability of a designated caregiver who monitors the patient's clinical situation and can collaborate in the assessment of outcomes and the provision of informed consent (ideally 8/h at least 3x/week)
- Shared perception between the attending neurologist and family members that the drug may no longer have a therapeutic effect, has been ineffective after a therapeutic trial, or the presence of side effects possibly attributed to the drugs.
Exclusion
- Life expectancy presumably less than the follow-up period (6 months);
- Unstable medical or surgical condition that can significantly interfere with the patient's overall health status;
- Another pathology interfering with cognitive functioning (HIV, brain tumor, encephalitis, demyelinating disease);
- Introduction of an antipsychotic drug in the last month.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05321680
Start Date
March 1 2021
End Date
March 20 2022
Last Update
April 11 2022
Active Locations (1)
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1
Centro Hospitalar Universitário de São João
Porto, Portugal, 4200-319