Trial · NCT04117178

Monitoring Anti-Dementia Drugs by Serum Levels

NCT04117178, Phase 4, Completed, Zealand University Hospital; results first posted 2025-02-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Monitoring Anti-Dementia Drugs by Serum Levels. Trials, record NCT04117178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04117178

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Monitoring Anti-Dementia Drugs by Serum Levels
NCT number: NCT04117178
Status: Completed
Phases: Phase 4
Enrollment: 132 participants, actual
Lead sponsor: Zealand University Hospital
Conditions: Dementia, Dementia With Lewy Bodies, Dementia in Parkinsons Disease, Dementia Alzheimers, Alzheimer Disease
Interventions: Donepezil, Memantine, Measurement of serum level of anti-dementia drug
First posted: 2019-10-07
Last updated: 2025-02-10
Other registries' IDs: eudract:2017-002707-10
Results first posted: 2025-02-10

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change of Mini Mental State Examination (MMSE) Test Result	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).
Primary	Change of Adenbrooke's Cognitive Examination (ACE) Test Result	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).
Primary	Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.	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.
Primary	Level of Compliance to Treatment	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)
Secondary	Change of Clinical Global Impression (CGI) Score Result	1 year (enrollment in study and at 1-year follow-up)	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).
Secondary	Change in Geriatric Depression Scale (GDS) Symptoms Score	The GDS is administered to all participants at the both the baseline and 12-month follow-up visit.	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).
Secondary	Change of Disability Assessment for Dementia (DAD) Score Result	1 year (enrollment in study and at 1-year follow-up)	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)
Secondary	Change of Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Result	1 year (enrollment in study and at 1-year follow-up)	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).
Secondary	C2D6 Phenotype	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.	Cyp2D6 is the gene which expresses the enzyme CYP2D6. Donepezil is metabolized by CYP2D6.
Secondary	Genetic Test for BcHE K Variant	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.	BcHE butyryl cholinesterase (BChE), K variant.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change of Mini Mental State Examination (MMSE) Test Result	1 year (enrollment in study and at 1-year follow-up)	difference in MMSE units on a scale	MEAN
PRIMARY	Change of Adenbrooke's Cognitive Examination (ACE) Test Result	1 year (enrollment in study and at 1-year follow-up)	difference in ACE units on a scale	MEAN
PRIMARY	Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.	Counted at the 12 month visit	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Level of Compliance to Treatment	Level of compliance will be scored at the one year follow-up by both questioning the participant and the primary relative.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change of Clinical Global Impression (CGI) Score Result	1 year (enrollment in study and at 1-year follow-up)	score on a scale	MEAN
SECONDARY	Change in Geriatric Depression Scale (GDS) Symptoms Score	The GDS is administered to all participants at the both the baseline and 12-month follow-up visit.	units on a scale	MEAN
SECONDARY	Change of Disability Assessment for Dementia (DAD) Score Result	1 year (enrollment in study and at 1-year follow-up)	difference in DAD units on a scale	MEAN
SECONDARY	Change of Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Result	1 year (enrollment in study and at 1-year follow-up)	difference in NPI units on a scale	MEAN
SECONDARY	C2D6 Phenotype	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Genetic Test for BcHE K Variant	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.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change of Mini Mental State Examination (MMSE) Test Result	Standard of Care		-0.27	Standard Deviation 3.19	difference in MMSE units on a scale
Change of Mini Mental State Examination (MMSE) Test Result	Intervention Arm		-0.90	Standard Deviation 3.56	difference in MMSE units on a scale
Change of Adenbrooke's Cognitive Examination (ACE) Test Result	Standard of Care		-3.76	Standard Deviation 6.56	difference in ACE units on a scale
Change of Adenbrooke's Cognitive Examination (ACE) Test Result	Intervention Arm		-4.02	Standard Deviation 9.01	difference in ACE units on a scale
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.	Standard of Care	Within TRR	23		Participants
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.	Intervention Arm	Within TRR	23		Participants
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.	Standard of Care	Outside TRR	26		Participants
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.	Intervention Arm	Outside TRR	35		Participants
Level of Compliance to Treatment	Standard of Care	Completely regular	48		Participants
Level of Compliance to Treatment	Intervention Arm	Completely regular	55		Participants

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard of Care	65
Overall Study	STARTED	Intervention Arm	67
Overall Study	COMPLETED	Standard of Care	49
Overall Study	COMPLETED	Intervention Arm	58
Overall Study	NOT COMPLETED	Standard of Care	16
Overall Study	NOT COMPLETED	Intervention Arm	9

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	various minor non-related events	General disorders	Standard of Care	42	65	42
other	various minor non-related events	General disorders	Intervention Arm	46	67	46
serious	Cholecystitis	Hepatobiliary disorders	Standard of Care	0	65	0
serious	Cholecystitis	Hepatobiliary disorders	Intervention Arm	1	67	1
serious	Psychosis	Psychiatric disorders	Standard of Care	1	65	1
serious	Psychosis	Psychiatric disorders	Intervention Arm	0	67	0
serious	Psychosis	Psychiatric disorders	Standard of Care	0	65	0
serious	Psychosis	Psychiatric disorders	Intervention Arm	1	67	1
serious	Death	Surgical and medical procedures	Standard of Care	1	65	1
serious	Death	Surgical and medical procedures	Intervention Arm	0	67	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard of Care	2	65
Total, all-cause mortality	Intervention Arm	2	67
Total, other adverse events	Standard of Care	42	65
Total, other adverse events	Intervention Arm	46	67
Total, serious adverse events	Standard of Care	6	65
Total, serious adverse events	Intervention Arm	7	67

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40034344	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention Arm vs Standard of Care: deaths from any cause	Trial comparisons
Intervention Arm vs Standard of Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04117178

GET https://conductscience.org/api/trials/v1/NCT04117178/results?page=2

API reference For AI assistants