Status:
COMPLETED
Monitoring Anti-Dementia Drugs by Serum Levels
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Filadelfia Epilepsy Hospital
Conditions:
Dementia
Dementia With Lewy Bodies
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main objective of the MONANTI study is twofold: Firstly, to determine the serum concentration (SC) the anti-dementia drugs donepezil and memantine in a broadly defined clinical population of pati...
Eligibility Criteria
Inclusion
- The following 3 inclusion criteria (A+B+C) must be met:
- A. Participant must be newly diagnosed with one of the three conditions below
- Alzheimer's disease dementia
- dementia with Lewy Bodies
- Dementia in Parkinson's disease B. Participant must be prescribed either donepezil or memantine at enrollment. C. Participant must be able to give informed consent to participation in the study.
Exclusion
- no accompanying relative at the enrollment and/or follow-up visits
- patients living alone who do not receive help to administer medication.
- lack of ability to cooperate, including severely reduced vision or impaired hearing and/or other severe disabilities.
- patients unable to give informed consent in a meaningful sense due to cognitive decline at enrollment.
- known psychiatric disease (schizophrenia, bipolar affective disorder etc.). However, patients suffering from depression are eligible if they have been in continuously medically treated for at least 3 months prior to enrollment.
- known neurologic disorder, which by it self could contribute to cognitive symptoms.
- other known medical condition (kidney-, liver-, metabolic disease etc.) which by itself could contribute to cognitive symptoms.
- treatment with anti-psychotic drugs within 3 months of possible enrollment. A minimal daily dosage of benzodiazepine is deemed permissable for enrollment.
- patients with a history of substantial previous abuse of alcohol or drugs. Also, any kind of substance abuse within last 3 months.
- any previous severe trauma to the head or neuroinfections which could contribute to cognitive symptoms.
- electro convulsive treatment within last 3 months.
- anesthesia within last 3 months
Key Trial Info
Start Date :
February 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04117178
Start Date
February 4 2020
End Date
February 16 2023
Last Update
February 10 2025
Active Locations (1)
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1
Regionalt Videnscenter for Demens
Roskilde, Region Sjælland, Denmark, 4000