Trial Outcomes & Findings for Monitoring Anti-Dementia Drugs by Serum Levels (NCT NCT04117178)
NCT ID: NCT04117178
Last Updated: 2025-02-10
Results Overview
Widely used clinical test for brief assesment of cognitive function. Total score ranging from 0 (worst) to 30 (best).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
132 participants
Primary outcome timeframe
1 year (enrollment in study and at 1-year follow-up)
Results posted on
2025-02-10
Participant Flow
A total of 132 participants recruited because a total of 110 participants assessable at the 6 month visit were needed.
Participant milestones
| Measure |
Standard of Care
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
67
|
|
Overall Study
COMPLETED
|
49
|
58
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monitoring Anti-Dementia Drugs by Serum Levels
Baseline characteristics by cohort
| Measure |
Standard of Care
n=65 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=67 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Age, Continuous
|
76.0 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
74.4 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
75.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
65 participants
n=5 Participants
|
67 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Change of Mini Mental State Examination (MMSE) Test Result
|
-0.27 difference in MMSE units on a scale
Standard Deviation 3.19
|
-0.90 difference in MMSE units on a scale
Standard Deviation 3.56
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Change of Adenbrooke's Cognitive Examination (ACE) Test Result
|
-3.76 difference in ACE units on a scale
Standard Deviation 6.56
|
-4.02 difference in ACE units on a scale
Standard Deviation 9.01
|
PRIMARY outcome
Timeframe: Counted at the 12 month visitPercentage 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.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.
Within TRR
|
23 Participants
|
23 Participants
|
|
Percentage of Participants With a Serum Concentration Within the Therapeutic Reference Range (TRR) at 12 Month Follow-up Visit.
Outside TRR
|
26 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Level of Compliance to Treatment
Completely regular
|
48 Participants
|
55 Participants
|
|
Level of Compliance to Treatment
Regular
|
1 Participants
|
1 Participants
|
|
Level of Compliance to Treatment
Less regular
|
0 Participants
|
2 Participants
|
|
Level of Compliance to Treatment
Irregular
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Change of Clinical Global Impression (CGI) Score Result
|
4.68 score on a scale
Standard Deviation 1.06
|
4.62 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Change in Geriatric Depression Scale (GDS) Symptoms Score
|
-0.57 units on a scale
Standard Deviation 2.47
|
0.79 units on a scale
Standard Deviation 2.55
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Change of Disability Assessment for Dementia (DAD) Score Result
|
-0.07 difference in DAD units on a scale
Standard Deviation 0.13
|
-0.10 difference in DAD units on a scale
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Change of Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Result
|
2.40 difference in NPI units on a scale
Standard Deviation 6.34
|
1.30 difference in NPI units on a scale
Standard Deviation 3.18
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
C2D6 Phenotype
Ultrafast metabolizer
|
0 Participants
|
1 Participants
|
|
C2D6 Phenotype
Extensive metabolizer
|
42 Participants
|
49 Participants
|
|
C2D6 Phenotype
Intermediate metabolizer
|
5 Participants
|
5 Participants
|
|
C2D6 Phenotype
Poor metabolizer
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Genetic Test for BcHE K Variant
Wildtype/Wildtype
|
29 Participants
|
37 Participants
|
|
Genetic Test for BcHE K Variant
Wildtype/mutant
|
18 Participants
|
18 Participants
|
|
Genetic Test for BcHE K Variant
mutant/mutant
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For participants who complete the trial APOe4 allele status is assessed at the 1 year visit.The APOe4 allele is linked to an increased risk of developing Alzheimer's disease.
Outcome measures
| Measure |
Standard of Care
n=49 Participants
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=58 Participants
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Genetic Test for APOe4 Allele Status.
APOE2/APOE2
|
0 Participants
|
1 Participants
|
|
Genetic Test for APOe4 Allele Status.
APOE2/APOE3
|
1 Participants
|
1 Participants
|
|
Genetic Test for APOe4 Allele Status.
APOE2/APOE4
|
1 Participants
|
1 Participants
|
|
Genetic Test for APOe4 Allele Status.
APOE3/APOE3
|
10 Participants
|
17 Participants
|
|
Genetic Test for APOe4 Allele Status.
APOE3/APOE4
|
31 Participants
|
28 Participants
|
|
Genetic Test for APOe4 Allele Status.
APOE4/APOE4
|
6 Participants
|
10 Participants
|
Adverse Events
Standard of Care
Serious events: 6 serious events
Other events: 42 other events
Deaths: 2 deaths
Intervention Arm
Serious events: 7 serious events
Other events: 46 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Standard of Care
n=65 participants at risk
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=67 participants at risk
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/65 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/65 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Surgical and medical procedures
Death
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
0.00%
0/67 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Vascular disorders
Death
|
0.00%
0/65 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
General disorders
Donepezil overdose
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
0.00%
0/67 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Infections and infestations
COVID-19
|
0.00%
0/65 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Nervous system disorders
Hospitalization due to headache
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
0.00%
0/67 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Vascular disorders
synkope
|
0.00%
0/65 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Nervous system disorders
Stroke
|
0.00%
0/65 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
1.5%
1/67 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to lung cancer with metastases
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
0.00%
0/67 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
|
Surgical and medical procedures
Antebrachium facture
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
0.00%
0/67 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
Other adverse events
| Measure |
Standard of Care
n=65 participants at risk
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.
Measurement of serum level of anti-dementia drug: 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.
|
Intervention Arm
n=67 participants at risk
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.
Donepezil: Adjustment of treatment with donepezil according to serum level.
Memantine: Adjustment of treatment with memantine according to serum level.
Measurement of serum level of anti-dementia drug: 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.
|
|---|---|---|
|
General disorders
various minor non-related events
|
64.6%
42/65 • Number of events 42 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
68.7%
46/67 • Number of events 46 • Adverse event data were collected for each participant from the date of enrollment until the day of completion, ie. approximately 1 year.
Details on all adverse events were collected and recorded according to the ICH E6 (R2) GCP guidelines. The primary investigator assessed whether an adverse event was classified as serious (Serious Adverse Event, SAE) or non-serious (non-serious adverse event, AE) and whether the event was related to the study drugs or not. Details on non-related SAEs and AEs were con not collected and reported according to prespecified criteria, instead a detailed description was given in the case report file.
|
Additional Information
Michael Fischer
Department of Neurology, Zealand University Hospital
Phone: +4547322800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place