Anti-Demans İlaçlarının Serum Düzeyleri ile İzlenmesi

Sade dilde özet

Bu çalışma, demans (dementia) tedavisinde kullanılan Donepezil ve Memantine ilaçlarının kandaki (serum) düzeylerinin ölçülerek izlenmesini incelemektedir. Çalışmaya, yeni tanı almış Alzheimer hastalığı (Alzheimer's disease), Lewy cisimcikli demans (dementia with Lewy bodies) veya Parkinson hastalığına bağlı demans olan ve donepezil ya da memantine reçete edilen kişiler alınmıştır. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

Zealand University Hospital

Müdahale

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

Başlangıç

04.02.2020

Tahmini bitiş

16.02.2023

Ülkeler

Denmark

İlgili genler

Merkezler

• Roskilde, Denmark

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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