Monitoring Anti-Dementia Drugs by Serum Levels

Plain-language summary

This study looks at monitoring the blood (serum) levels of the anti-dementia drugs Donepezil and Memantine. It enrolled people newly diagnosed with Alzheimer's disease, dementia with Lewy bodies, or dementia in Parkinson's disease who were prescribed donepezil or memantine. The study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Zealand University Hospital

Intervention

Donepezil, Memantine, Measurement of serum level of anti-dementia drug

Start date

2/4/2020

Estimated completion

2/16/2023

Countries

Denmark

Related genes

Locations

• Roskilde, Denmark

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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