Trial · NCT04117178
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Other | Genetic Test for APOe4 Allele Status. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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