Clinical trial · Observational
The Predictive Factors of Good Clinical Response to Cholinesterase Inhibitors in Alzheimer Disease and Mixed Dementia
The Predictive Factors of Good Clinical Response to Cholinesterase Inhibitors in Mild and Moderate Alzheimer Disease and Mixed Dementia: a Naturalistic Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background and objectives: The aims of this naturalistic study were: to analyze factors which could be predictive of good response to cholinesterase inhibitors (ChEI), such as: age, sex, schooling, mild (CDR 1) or moderate Alzheimer's disease (AD),(CDR 2), Apoliprotein epsilon 4 (APOE Ɛ4), among others, in their cognitive and clinical response. We also classified patients according to their response to Mini mental State of Examination (MMSE). Finally we saw the polymorphisms of APO E and cytochrome P450 2D6 (CYP2D6) and tried to correlate the response with different allelic forms of Apo E and among others with wild type homozygotes (wt/wt) and their polymorphisms (CYP2D6\*3,\*4, \*5, \*6 and 10) of CYP 2D6. Patients and Methods: 129 patients were diagnosed as AD or AD+cerebrovascular disease (CVD) mild or moderate. After 12 month-treatment, 97 patients completed the study. They were assessed (four) times. In the first visit, without taking ChEI, after 3, 6 and 12 month-treatment, they were taking donepezil or rivastigmine or galantamine. We also extracted 5 mL of blood sample to genotype the DNA. In each visit, we applied cognitive, functional, mood and behavior scales. Good responders were defined as those who scored \> 2 in MMSE. Results and Conclusion: In longitudinal analysis, patients with mild AD and good responders at 3 months were considered good responders at 12 months. We obtained a higher rate of good responders comparing with other researches (27.8%). There was no correlation between dose, APOE and CYP 2D6 polymorphisms, although we already obtained clinical results with the dose dosage of 5mg.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease, Late Onset | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholinesterase inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Alzheimer disease or mixed dementia
- description
- Patients were evaluated four times. In the first consultation, without taking cholinesterase inhibitors (ChEI), after three, six and 12 months taking ChEI.
- interventionNames
- Drug: cholinesterase inhibitors
Primary outcomes (1)
- measure
- Cognitive results
- timeFrame
- Patients were evaluated from 06/2009 to 03/2013 for four times - first visit ( without taking medication), after three, six and 12 months of treatment with cholinesterase inhibitors (up to 12 months)
- description
- Clinical assessment: The clinical domains examined and the respective evaluation tools were: global cognition - MMSE, clock drawing test score and Mattis Dementia Rating Scale - DRS). Patients were seen between 06/2009 to 03/2013. Good clinical responders were those who scored ≥ 2 on the MMSE after 12 month-treatment, the neutrals had the scores between -1 and +1, and bad responders scored ≤ -2 at the same period. A subgroup who scored \> 2 on the MMSE were defined as very good responders. Patients were seen for four times: at the first consultation (n=129), at three (n=114), six (n=105) and twelve months of treatment (n=97).
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 59 Years
- Maximum age
- 92 Years
Show eligibility criteria text
Inclusion Criteria: \- AD diagnosis or AD with CVD according the criteria of National Institute on Aging and the Alzheimer's Association workgroup and the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Exclusion Criteria: * Patients with mild cognitive impairment; * Other types of dementia, such as pure vascular dementia, frontotemporal dementia, dementia with Lewy bodies, corticobasal degeneration; * Severe dementia (CDR 3) * Those who were already taking ChEI, * If there have not been agreement between the first researcher and the treating physician.
References
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