MONANTI

CompletedPhase 4Results posted

Monitoring Anti-Dementia Drugs by Serum Levels

Monitoring Anti-Dementia Drugs by Serum Levels: Importance of Serum Levels, Drug-monitoring, Side-effects, Clinical Efficacy and Compliance (Translation of Official Danish Title)

Lead sponsor

Zealand University Hospital

Assets

Donepezil / Memantine

Listed sites

Recruiting sites

Enrollment

132

actual

Study population

Alzheimer’s disease, Lewy body dementia

Key I/E criterion

•Multiple dementia etiologies

Primary endpoints

•Mini-Mental State Examination (MMSE)•Serum Concentration Within the Therapeutic Reference Range (TRR)•Level of Compliance to Treatment

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2017-002707-10

NCT IDNCT04117178

Org study IDREG-007-2018

Timeline

Milestones

Study first posted2019-10-07actual

Study start2020-02-04actual

Primary completion2023-02-16actual

Study completion2023-02-16actual

Last update posted2025-02-10actual

Results first posted2025-02-10actual

Assets

Drug assets

Donepezil Memantine

Study populations

Who this study enrolls

Alzheimer’s diseaseLewy body dementia

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (22)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Behavior / neuropsychiatric

Function / daily living

Safety / tolerability / PK

Other clinical outcomes

Global cognition

4 endpoints

Primary/protocol endpoint

Change of Mini Mental State Examination (MMSE) Test Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Change of Adenbrooke's Cognitive Examination (ACE) Test Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

Mini-Mental State Examination (MMSE)

descriptive

Primary/registry result

Change of Mini Mental State Examination (MMSE) Test Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

Mini-Mental State Examination (MMSE)

descriptive

Posted result

Group	Value (mean), difference in MMSE units on a scale	Standard deviation
Standard of Caren=49 Participants	-0.27	3.19
Intervention Armn=58 Participants	-0.90	3.56

Primary/registry result

Change of Adenbrooke's Cognitive Examination (ACE) Test Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

Mini-Mental State Examination (MMSE)

descriptive

Posted result

Group	Value (mean), difference in ACE units on a scale	Standard deviation
Standard of Caren=49 Participants	-3.76	6.56
Intervention Armn=58 Participants	-4.02	9.01

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change of Disability Assessment for Dementia (DAD) Score Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

descriptive

Secondary/registry result

Change of Disability Assessment for Dementia (DAD) Score Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

descriptive

Posted result

Group	Value (mean), difference in DAD units on a scale	Standard deviation
Standard of Caren=49 Participants	-0.07	0.13
Intervention Armn=58 Participants	-0.10	0.16

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

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 from baseline, improvement

Secondary/protocol endpoint

Change of Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/registry result

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 from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Standard of Caren=49 Participants	-0.57	2.47
Intervention Armn=58 Participants	0.79	2.55

Secondary/registry result

Change of Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

Group	Value (mean), difference in NPI units on a scale	Standard deviation
Standard of Caren=49 Participants	2.40	6.34
Intervention Armn=58 Participants	1.30	3.18

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

threshold achievement, event

Primary/registry result

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

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Standard of CareWithin TRRn=49 Participants	23	-
Outside TRRn=49 Participants	26	-
Intervention ArmWithin TRRn=58 Participants	23	-
Outside TRRn=58 Participants	35	-

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Change of Clinical Global Impression (CGI) Score Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

descriptive

Secondary/registry result

Change of Clinical Global Impression (CGI) Score Result

Time frame:1 year (enrollment in study and at 1-year follow-up)

descriptive

Posted result

Group	Value (mean), score on a scale	Standard deviation
Standard of Caren=49 Participants	4.68	1.06
Intervention Armn=58 Participants	4.62	0.95

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

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.

descriptive

Primary/registry result/low confidence

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.

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Standard of CareCompletely regularn=49 Participants	48	-
Regularn=49 Participants	1	-
Less regularn=49 Participants	0	-
Irregularn=49 Participants	0	-
Intervention ArmCompletely regularn=58 Participants	55	-
Regularn=58 Participants	1	-
Less regularn=58 Participants	2	-
Irregularn=58 Participants	0	-

Secondary/protocol endpoint/low confidence

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.

descriptive

Secondary/protocol endpoint/low confidence

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.

descriptive

Secondary/registry result/low confidence

C2D6 Phenotype

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Standard of CareUltrafast metabolizern=49 Participants	0	-
Extensive metabolizern=49 Participants	42	-
Intermediate metabolizern=49 Participants	5	-
Poor metabolizern=49 Participants	2	-
Intervention ArmUltrafast metabolizern=58 Participants	1	-
Extensive metabolizern=58 Participants	49	-
Intermediate metabolizern=58 Participants	5	-
Poor metabolizern=58 Participants	3	-

Secondary/registry result/low confidence

Genetic Test for BcHE K Variant

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Standard of CareWildtype/Wildtypen=49 Participants	29	-
Wildtype/mutantn=49 Participants	18	-
mutant/mutantn=49 Participants	2	-
Intervention ArmWildtype/Wildtypen=58 Participants	37	-
Wildtype/mutantn=58 Participants	18	-
mutant/mutantn=58 Participants	3	-

Other/protocol endpoint/low confidence

Genetic Test for APOe4 Allele Status.

Time frame:For participants who complete the trial APOe4 allele status is assessed at the 1 year visit.

categorical status, descriptive

Other_pre_specified/registry result/low confidence

Genetic Test for APOe4 Allele Status.

Time frame:For participants who complete the trial APOe4 allele status is assessed at the 1 year visit.

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Standard of CareAPOE2/APOE2n=49 Participants	0	-
APOE2/APOE3n=49 Participants	1	-
APOE2/APOE4n=49 Participants	1	-
APOE3/APOE3n=49 Participants	10	-
APOE3/APOE4n=49 Participants	31	-
APOE4/APOE4n=49 Participants	6	-
Intervention ArmAPOE2/APOE2n=58 Participants	1	-
APOE2/APOE3n=58 Participants	1	-
APOE2/APOE4n=58 Participants	1	-
APOE3/APOE3n=58 Participants	17	-
APOE3/APOE4n=58 Participants	28	-
APOE4/APOE4n=58 Participants	10	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID40034344via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.