DementiaPhase 4MONANTINCT04117178
Monitoring Anti-Dementia Drugs by Serum Levels
A Phase 4 study testing Donepezil, Memantine and Measurement of serum level of anti-dementia drug in people with Dementia and Dementia With Lewy Bodies, run by Zealand University Hospital at 1 site in Denmark.
Trial 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 patients suffering from dementia treated with the two drugs in question. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Dementia With Lewy Bodies, Dementia in Parkinsons Disease
- What is being tested?
- Donepezil, Memantine and Measurement of serum level of anti-dementia drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Feb 2020to 16 Feb 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following 3 inclusion criteria (A+B+C) must be met:
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Regionalt Videnscenter for Demens
Roskilde, Region Sjælland, 4000
About this study
Official 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)
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 patients suffering from dementia treated with the two drugs in question. Secondly, to determine whether adjustment of treatment of anti-dementia medication based on measurements of the SC will benefit patients in terms of cognitive performance, activities of daily living (ADL), frequency and severity of side effects.
Read more
The reason for conduction of this study is that the relationship between serum-level of anti-dementia drugs, clinical efficacy, compliance and side effects has only been scarcely investigated.
Both a previously published study and a preliminary (pilot)study conducted imply that roughly 50 % of patients on donepezil have SC outside the recommended therapeutic reference range (TRR).
Thus, MONANTI will investigate if this is indeed the case in a broadly comprised population of patients with dementia treated with donepezil or memantine. In addition, MONANTI will link SC to co-morbidity, level of compliance, medication interactions. It is hypothesized that the efficacy of anti-dementia drugs can be significantly improved by adjustment of treatment according to SC. Also, it is hypothesized that the burden of side effects can be reduced in patients in whom too high SC are detected, if dose reduction or change of treatment drug is done.
MONANTI is a randomized study, in which the assessor is blinded to avoid related biases to the extent possible.
To meet the enrollment criteria eligible participants must:
- be newly diagnosed with either Alzheimer's disease dementia, dementia with Lewy-bodies or Parkinson's disease with dementia and B) be scheduled for treatment with either donepezil or memantine. C) not meet a list of (exclusion) criteria, which have been set up in order to avoid blur and biases of the results.
- be able to give written informed consent to participation in presence of a close relative.
After enrollment the participants will be randomly assigned to one of two study groups. In the first of these, the control group, the participants receive standard treatment and follow-up at the outpatient clinic. In addition, all participants in the control group who complete the trial will have a blood sample collected at the final visit to measure the SC of the anti-dementia drug along with a genetic test for a few key genes thought to be relevant for the study (two liver enzymes (cyp2D6, cyp3A4/5, APOE-genotype, butyrylcholine-esterase K-variant).
In the other group, the intervention group, the participators will be closely monitored for side effects after prescription of anti-dementia drugs. All participants in the intervention group will be offered a measurement of the SC in case they experience drug side effects within 2 months of treatment initiation. All participants in the intervention group will have a measurement of the SC done at the 6 months visit. The measured SC will be compared to the TRR of the drug in question. This information, along with details from the clinical assessment at the 6 month visit will be used to guide the decision of whether or not to adjust treatment. All decisions on treatment adjustment during the trial are done by the PI according to details in the protocol.
All participants in the intervention group are evaluated again at a 12 month visit, identical to that of the control groups.
To assess the possible effects of SC guided treatment adjustment six clinical tests/rating scales will be used (MMSE, ACE, NPI-Q, DAD, CGI, GDS). The tests/rating scales will be administered both at the enrollement visit and one year later at the final 12 month follow-up visit.
To measure the effect of donepezil on brain cholinergic function approx. 30 participants will be recruited for electroencephalography (EEG). These participants will have an EEG done at enrollment and after 12 months.
In addition to the above mentioned quantitative study a qualitative study with relatives of enrolled participants is planned.
All the needed approvals have been obtained according to Danish law (approval by the Danish Data Protection Agency, Scientific Ethics Committee for Region Sjaelland, The Danish Medical Agencies).
- Conditions
- Dementia, Dementia With Lewy Bodies, Dementia in Parkinsons Disease, Dementia Alzheimers, Alzheimer Disease
- Being tested
- Donepezil, Memantine, Measurement of serum level of anti-dementia drug
- Keywords
- Therapeutic Drug Monitoring, TDM, Adverse effects, Dementia, Alzheimer's disease
- Medical subject headings
- Dementia, Lewy Body Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Adjustment of treatment with donepezil according to serum level.
MemantineDrug
Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drugDiagnostic test
Participants allocated to the intervention arm are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention group not experiencing side effects will have their treatment adjusted after 6 months based upon serum levels of the drug in question.
Participants allocated to the standard of care arm follow the usual routines of the dementia clinic but are requested to have the serum level of the prescribed drug and CYP2D6-genotype measured after 12 month.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Participants allocated to this arm follow the usual routines of the out patient dementia clinic but are requested to have the serum level of the prescribed drug measured after 12 month. Also, CYP2D6, BcHE K and APOe4 status will be determined after 12 months. Receives: Diagnostic Test: Measurement of serum level of anti-dementia drug |
| Intervention arm | Experimental | Participants allocated to this arm follow are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention arm not experiencing side effects will have their treatment adjusted after 6 months based upon serum level of the drug in question. Receives: Drug: Donepezil; Drug: Memantine; Diagnostic Test: Measurement of serum level of anti-dementia drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mini Mental State Examination (MMSE) Test Result
Widely used clinical test for brief assesment of cognitive function. Total score ranging from 0 (worst) to 30 (best).
Measured: 1 year (enrollment in study and at 1-year follow-up)
Change of Adenbrooke's Cognitive Examination (ACE) Test Result
Widely used clinical test for assesment of cognitive function. The total score ranges from 0 (worst) 100 (best) and includes the score of the MMSE test (0-30).
Measured: 1 year (enrollment in study and at 1-year follow-up)
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.
Percentage of participans in each group with serum concentrations of the study drugs within the therapeutic reference range (TRR) at the 12 month follow-up visit.
According to the 2017 AGNP consensus guidelines the TRRs are "ranges of drug concentrations in blood that specify a lower limit below which a drug induced therapeutic response is relatively unlikely to occur and an upper limit above which tolerability decreases or above which it is relatively unlikely that therapeutic improvement may be still enhanced" (Pharmacopsychiatry . 2018 Jan;51(1-02):9-62. doi: 10.1055/s-0043-116492. Epub 2017 Sep 14).
Donepezil has a serum TRR of 50-75 nanograms per milliliter (ng/mL) and memantine has a serum TRR of 90-150 ng/mL.
Measured: Counted at the 12 month visit
Level of Compliance to Treatment
The level to which the medication has been ingested as prescribed. Both the participant him/her self is questioned as is the primary relative. The level of compliance is rated as belonging to one of the four categories: 1) 'completely regular drug intake' (no missed daily doses within 6 months), 2 'regular drug intake' (less than 10 missed daily doses within 6 months), 3) 'less regular drug intake' (10 - 30 missed daily doses with 6 months), 4) 'irregular drug intake' (more than 30 missed daily doses within 6 months)
Measured: Level of compliance will be scored at the one year follow-up by both questioning the participant and the primary relative.
Secondary outcomes (6)
Change of Clinical Global Impression (CGI) Score Result
The overall clinical impression of the clinical response to treatment as assessed by the investigator. Ranges from 1 (very much improved) to 7 (very much worse).
Measured: 1 year (enrollment in study and at 1-year follow-up)
Change in Geriatric Depression Scale (GDS) Symptoms Score
The Geriatric Depression Scale (GDS) is a questionaire administered by the investigator to the participant. GDS is used to assess symptoms of depression in the elderly. A 15 item version of the GDS is used with a score from 0 (best) to 15 (worst).
Measured: The GDS is administered to all participants at the both the baseline and 12-month follow-up visit.
Change of Disability Assessment for Dementia (DAD) Score Result
A questionaire filled in by the primary relative of the participant. DAD measures the impact of dementia symptoms on activities of daily living (ADL), including eating, dressing, personal hygiene. Total score ranges from 0 (worst) to 40 (best)
Measured: 1 year (enrollment in study and at 1-year follow-up)
Change of Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Result
A questionaire filled in by the primary relative of the participant. NPI-Q measures the severity of neuropsychiatric symptoms of demented patients. The total score ranges between 0 (best) and (36 worst).
Measured: 1 year (enrollment in study and at 1-year follow-up)
C2D6 Phenotype
Cyp2D6 is the gene which expresses the enzyme CYP2D6. Donepezil is metabolized by CYP2D6.
Measured: 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 BcHE K Variant
BcHE butyryl cholinesterase (BChE), K variant.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start4 Feb 2020
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded, randomized study with two arms: 'standard of care' arm and 'intervention' arm. Participants in the intervention arm will have their treatment adjusted according to Serum levels of the anti-dementia drug prescribed.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital
- Responsible party
- Sponsor
- Investigators
- Peter Høgh, MD, ph.d., Principal investigator, Regionalt Videnscenter for DemensMichael Fischer, MD, Study director, Regionalt Videnscenter for Demens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117178
- Sponsor's protocol ID
- REG-007-2018
- Other IDs
- 2017-002707-10, 2017
- Acronym
- MONANTI
- Status last verified
- Jul 2023
- First submitted
- 30 Sep 2019
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fischer MHF, Zibrandtsen IC, Johannsen P, Siersma V, Rasmussen JB, Larsen JB, Hogh P. Therapeutic drug monitoring for dose optimization in Alzheimer's disease and in dementia with Lewy bodies: A randomized single-blinded clinical trial. J Alzheimers Dis Rep. 2024 Nov 24;8(1):1516-1528. doi: 10.1177/25424823241289373. eCollection 2024.
PubMed 40034344
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04117178
- Acronym / sponsor ID
- MONANTI / REG-007-2018
- Conditions
- Dementia, Dementia With Lewy Bodies, Dementia in Parkinsons Disease, Dementia Alzheimers, Alzheimer Disease
- Keywords
- Therapeutic Drug Monitoring, TDM, Adverse effects, Dementia, Alzheimer's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Filadelfia Epilepsy Hospital
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients suffering from dementia treated with the two drugs in question. Secondly, to determine whether adjustment of treatment of anti-dementia medication based on measurements of the SC will benefit patients in terms of cognitive performance, activities of daily living (ADL), frequency and severity of side effects.
The reason for conduction of this study is that the relationship between serum-level of anti-dementia drugs, clinical efficacy, compliance and side effects has only been scarcely investigated.
Both a previously published study and a preliminary (pilot)study conducted imply that roughly 50 % of patients on donepezil have SC outside the recommended therapeutic reference range (TRR).
Thus, MONANTI will investigate if this is indeed the case in a broadly comprised population of patients with dementia treated with donepezil or memantine. In addition, MONANTI will link SC to co-morbidity, level of compliance, medication interactions. It is hypothesized that the efficacy of anti-dementia drugs can be significantly improved by adjustment of treatment according to SC. Also, it is hypothesized that the burden of side effects can be reduced in patients in whom too high SC are detected, if dose reduction or change of treatment drug is done.
MONANTI is a randomized study, in which the assessor is blinded to avoid related biases to the extent possible.
To meet the enrollment criteria eligible participants must:
- be newly diagnosed with either Alzheimer's disease dementia, dementia with Lewy-bodies or Parkinson's disease with dementia and B) be scheduled for treatment with either donepezil or memantine. C) not meet a list of (exclusion) criteria, which have been set up in order to avoid blur and biases of the results.
- be able to give written informed consent to participation in presence of a close relative.
After enrollment the participants will be randomly assigned to one of two study groups. In the first of these, the control group, the participants receive standard treatment and follow-up at the outpatient clinic. In addition, all participants in the control group who complete the trial will have a blood sample collected at the final visit to measure the SC of the anti-dementia drug along with a genetic test for a few key genes thought to be relevant for the study (two liver enzymes (cyp2D6, cyp3A4/5, APOE-genotype, butyrylcholine-esterase K-variant).
In the other group, the intervention group, the participators will be closely monitored for side effects after prescription of anti-dementia drugs. All participants in the intervention group will be offered a measurement of the SC in case they experience drug side effects within 2 months of treatment initiation. All participants in the intervention group will have a measurement of the SC done at the 6 months visit. The measured SC will be compared to the TRR of the drug in question. This information, along with details from the clinical assessment at the 6 month visit will be used to guide the decision of whether or not to adjust treatment. All decisions on treatment adjustment during the trial are done by the PI according to details in the protocol.
All participants in the intervention group are evaluated again at a 12 month visit, identical to that of the control groups.
To assess the possible effects of SC guided treatment adjustment six clinical tests/rating scales will be used (MMSE, ACE, NPI-Q, DAD, CGI, GDS). The tests/rating scales will be administered both at the enrollement visit and one year later at the final 12 month follow-up visit.
To measure the effect of donepezil on brain cholinergic function approx. 30 participants will be recruited for electroencephalography (EEG). These participants will have an EEG done at enrollment and after 12 months.
In addition to the above mentioned quantitative study a qualitative study with relatives of enrolled participants is planned.
All the needed approvals have been obtained according to Danish law (approval by the Danish Data Protection Agency, Scientific Ethics Committee for Region Sjaelland, The Danish Medical Agencies).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single blinded, randomized study with two arms: 'standard of care' arm and 'intervention' arm. Participants in the intervention arm will have their treatment adjusted according to Serum levels of the anti-dementia drug prescribed.
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Diagnostic Test: Measurement of serum level of anti-dementia drugParticipants allocated to this arm follow the usual routines of the out patient dementia clinic but are requested to have the serum level of the prescribed drug measured after 12 month. Also, CYP2D6, BcHE K and APOe4 status will be determined after 12 months. |
| Intervention arm | Experimental | Drug: Donepezil, Drug: Memantine, Diagnostic Test: Measurement of serum level of anti-dementia drugParticipants allocated to this arm follow are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention arm not experiencing side effects will have their treatment adjusted after 6 months based upon serum level of the drug in question. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilAdjustment of treatment with donepezil according to serum level. | Drug | Intervention arm |
| MemantineAdjustment of treatment with memantine according to serum level. | Drug | Intervention arm |
| Measurement of serum level of anti-dementia drugParticipants allocated to the intervention arm are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention group not experiencing side effects will have their treatment adjusted after 6 months based upon serum levels of the drug in question. Participants allocated to the standard of care arm follow the usual routines of the dementia clinic but are requested to have the serum level of the prescribed drug and CYP2D6-genotype measured after 12 month. | Diagnostic test | Intervention arm, Standard of care |
Primary outcome
Change of Mini Mental State Examination (MMSE) Test Result
Time frame: 1 year (enrollment in study and at 1-year follow-up)
Widely used clinical test for brief assesment of cognitive function. Total score ranging from 0 (worst) to 30 (best).
Change of Adenbrooke's Cognitive Examination (ACE) Test Result
Time frame: 1 year (enrollment in study and at 1-year follow-up)
Widely used clinical test for assesment of cognitive function. The total score ranges from 0 (worst) 100 (best) and includes the score of the MMSE test (0-30).
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.
Time frame: Counted at the 12 month visit
Percentage of participans in each group with serum concentrations of the study drugs within the therapeutic reference range (TRR) at the 12 month follow-up visit. According to the 2017 AGNP consensus guidelines the TRRs are "ranges of drug concentrations in blood that specify a lower limit below which a drug induced therapeutic response is relatively unlikely to occur and an upper limit above which tolerability decreases or above which it is relatively unlikely that therapeutic improvement may be still enhanced" (Pharmacopsychiatry . 2018 Jan;51(1-02):9-62. doi: 10.1055/s-0043-116492. Epub 2017 Sep 14). Donepezil has a serum TRR of 50-75 nanograms per milliliter (ng/mL) and memantine has a serum TRR of 90-150 ng/mL.
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.
The level to which the medication has been ingested as prescribed. Both the participant him/her self is questioned as is the primary relative. The level of compliance is rated as belonging to one of the four categories: 1) 'completely regular drug intake' (no missed daily doses within 6 months), 2 'regular drug intake' (less than 10 missed daily doses within 6 months), 3) 'less regular drug intake' (10 - 30 missed daily doses with 6 months), 4) 'irregular drug intake' (more than 30 missed daily doses within 6 months)
6 secondary outcomes
Change of Clinical Global Impression (CGI) Score Result
Time frame: 1 year (enrollment in study and at 1-year follow-up)
Change in Geriatric Depression Scale (GDS) Symptoms Score
Time frame: The GDS is administered to all participants at the both the baseline and 12-month follow-up visit.
Change of Disability Assessment for Dementia (DAD) 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)
C2D6 Phenotype
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 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40034344Fischer MHF, Zibrandtsen IC, Johannsen P, Siersma V, Rasmussen JB, Larsen JB, Hogh P. Therapeutic drug monitoring for dose optimization in Alzheimer's disease and in dementia with Lewy bodies: A randomized single-blinded clinical trial. J Alzheimers Dis Rep. 2024 Nov 24;8(1):1516-1528. doi: 10.1177/25424823241289373. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Høgh, MD, ph.d. principal investigator
Regionalt Videnscenter for Demens
Michael Fischer, MD study director
Regionalt Videnscenter for Demens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil, Memantine and Measurement of serum level of anti-dementia drug in people with Dementia and Dementia With Lewy Bodies, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Mini Mental State Examination (MMSE) Test Result (time frame: 1 year (enrollment in study and at 1-year follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.