NCT04117178 · Phase 4 · COMPLETED
Monitoring Anti-Dementia Drugs by Serum Levels
This Phase 4 trial is testing whether measuring the actual blood levels of two common dementia drugs, donepezil and memantine, helps doctors fine-tune the dose for better results and fewer side effects. Phase 4 means the drugs are already approved — this is about using them more precisely. Researchers will compare patients whose dosing is guided by blood level measurements against patients receiving standard care, tracking cognition and daily functioning over 12 months.
Eligibility criteria
Inclusion Criteria: 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 Criteria: * 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-10