Monitoring Anti-Dementia Drugs by Serum Levels

• Register: ClinicalTrials.gov
• Last refreshed on: 24 April 2023
• Main ID: NCT04117178
• Date of registration: 30/09/2019
• Prospective Registration: Yes
• Primary sponsor: Zealand University Hospital
• Public title: Monitoring Anti-Dementia Drugs by Serum Levels MONANTI
• Scientific title: Monitoring Anti-Dementia Drugs by Serum Levels: Importance of Serum Levels, Drug-monitoring, Side-effects, Clinical Efficacy and Compliance (Translation of Official Danish Title)
• Date of first enrolment: February 4, 2020
• Target sample size: 132
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04117178
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Michael Fischer, MD
• Affiliation: Regionalt Videnscenter for Demens

• Name: Peter Høgh, MD, ph.d.
• Affiliation: Regionalt Videnscenter for Demens

Key inclusion & exclusion 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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dementia in Parkinsons Disease

Dementia Alzheimers

Dementia With Lewy Bodies

Alzheimer Disease

Dementia

Intervention(s)

Diagnostic Test: Measurement of serum level of anti-dementia drug

Drug: Donepezil

Drug: Memantine

Primary Outcome(s)

Serum level of memantine [Time Frame: For participants in the standard of care arm this will be measured 1 year after enrollment. For participants in the intervention group serum level will be measured within 2 months if side effects are experienced, if not then after 6 months.]

Level of compliance to treatment [Time Frame: Level of compliance will be scored at the one year follow-up by both questioning the participant and the primary relative.]

Change in Geriatric Depression Scale (GDS) symptoms score [Time Frame: All participators will be requested to fill in the GDS questionaire at enrollment and at 12 months follow-up.]

Change of Adenbrooke's Cognitive Exam (ACE) test result [Time Frame: 1 year (enrollment in study and at 1-year follow-up)]

Change of Clinical Global Impression (CGI) score result [Time Frame: 1 year (enrollment in study and at 1-year follow-up)]

Change of Neuropsychiatric Inventory Questionnaire (NPI-Q) score result [Time Frame: 1 year (enrollment in study and at 1-year follow-up)]

Change of Disability Assessment for Dementia (DAD) score result [Time Frame: 1 year (enrollment in study and at 1-year follow-up)]

Change of Mini Mental State Examination (MMSE) test result [Time Frame: 1 year (enrollment in study and at 1-year follow-up)]

Serum level of donepezil [Time Frame: For participants in the standard of care arm will this be measured 1 year after enrollment. For participants in the intervention arm serum level will be measured within 2 months if side effects are experienced, if not then after 6 months.]

Secondary Outcome(s)

genetic test for BcHE K variant [Time Frame: For participants in the standard of care arm BcHE K variant status will be tested 1 year after enrollment. For participants in the intervention arm BcHE K variant status will be determined at the 6 month follow-up.]

Change in quantitative electroencephalogram (qEEG) [Time Frame: qEEG done within 2 weeks after enrollment and after 6 months]

Cyp2D6 gene test [Time Frame: For participants in the standard of care arm CYP2D6 status will be determined 1 year after enrollment. For participants in the intervention arm Cyp2D6 will be tested within 2 months if side effects are experienced, if not then after 6 months.]

genetic test for APOe4 allele status. [Time Frame: For participants in the standard of care arm APOe4 allele status will be determined 1 year after enrollment. APOe4 allele status will be determined at the 6 month follow-up for participants in the intervention arm.]

Secondary ID(s)

2017-002707-10

REG-007-2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Filadelfia Epilepsy Hospital