An observational study in Alzheimer Disease, sponsored by University of the Philippines. Recruiting at 1 site in Philippines. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by University of the Philippines · Observational
This study will explore the different factors associated with drug response to acetylcholinesterase (AChE) inhibitor (donepezil) and NMDA receptor antagonist (memantine) in patients with Alzheimer's Disease.
These patients will be grouped according to the medications prescribed by their attending physician at baseline, 3rd month, and 6th month of follow up:
They will be observed for treatment response for up to 6 months.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 60 is below the median of 200 across 814 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of the Philippines is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All elderly patients from (1) University of the Philippines - Philippine General Hospital; (2) The Medical City; and (3) Cardinal Santos Medical Center that meet the eligibility criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort includes those with the disease and given AChE inhibitor monotherapy only
Drug: AChE inhibitor monotherapy
This cohort includes those with the disease, given AChE inhibitor and NMDA receptor antagonist combination therapy
Drug: AChE inhibitor and NMDA receptor antagonist combination therapy
This is a drug treatment using Donepezil only
Also known as: Donepezil
This is a drug treatment combining Donepezil and Memantine
Also known as: Donepezil and Memantine combination therapy
Change in gene signatures
Gene signatures obtained via whole exome sequencing
Time frame: Baseline, 3rd month, 6th month
Change in gut microbiome metabolome signatures
Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling
Time frame: Baseline, 3rd month, 6th month
Change in metabolome signatures
Metabolome signatures obtained via untargeted metabolomic profiling
Time frame: Baseline, 3rd month, 6th month
Change in levels of cognition using the Montreal Cognitive Assessment-Philippines (MoCA-P)
Montreal Cognitive Assessment-Philippines (MoCA-P) is an assessment tool used to measure mild cognitive impairment and early Alzheimer's disease. Scores range from 0-30. A score below 21 signifies mild cognitive impairment or early Alzheimer's disease.
Time frame: Baseline, 3rd month, 6th month
Change in levels of cognition using the Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) is an assessment tool used to measure cognitive aspects of mental functions, with scores ranging from 0-30, with lower scores indicating increasing levels of cognitive impairment.
Time frame: Baseline, 3rd month, 6th month
Change in levels of cognition using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) assesses the severity of cognitive dysfunction in Alzheimer's Disease patients. Scores range from 0-94, with higher scores indicating increased levels of cognitive dysfunction.
Time frame: Baseline, 3rd month, 6th month
Change in levels of functioning using the Katz Index of Activities of Daily Living (IADL) scale
The Katz IADL assesses the patient's need for assistance in performing basic activities of daily living. Possible scores range from 0-12, with a higher score indicating better levels of functioning.
Time frame: Baseline, 3rd month, 6th month
Change in levels of functioning using the Lawton instrumental activities of daily living (IADL) scale
The Lawton IADL assesses the patient's ability to carry out more complex tasks of daily living. Scores range from 0 indicating low function and dependent up to 16 indicating highly functional and independent.
Time frame: Baseline, 3rd month, 6th month
Changes in levels of behaviour using the Neuropsychiatric inventory (NPI) scale
The neuropsychiatric inventory (NPI) scale is an informant-based interview that assesses neuropsychiatric symptoms in terms of frequency, severity, and levels of distress. Scores range from 0 to 144, with higher scores indicating the presence of more neuropsychiatric symptoms.
Time frame: Baseline, 3rd month, 6th month
Change in levels of family functioning using the Filipino Family APGAR
Filipino family APGAR is a tool to assess family functioning based on five parameters: Adaptability, Partnership, Growth, Affection, and Resolve. The total scores range from 0 to 10 with higher scores indicating higher levels of satisfaction with family functioning.
Time frame: Baseline, 3rd month, 6th month
Change in levels of family functioning using the SCREEM Family Resources Survey (SCREEM-RES)
The SCREEM Family Resources Survey (SCREEM-RES) is a tool used to measure family resources that the family utilizes to cope with difficult situations. Scores range from 0 to 36, with higher scores indicating adequate levels of family resources.
Time frame: Baseline, 3rd month, 6th month
Plan to share: No
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University of the Philippines