Monitoring Drug Efficacy in Patients with Alzheimer's Disease
ConditionAlzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of the Philippines
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
newly diagnosed with mild or moderate dementia using the Montreal Cognitive Assessment and Clinical Dementia Rating (CDR) performed by a licensed psychometrician
clinically diagnosed by an expert adult neurologist as having probable AD using the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
treatment naive for any acetylcholinesterase inhibitors or memantine OR those who have not taken any acetylcholinesterase inhibitors or memantine in the last three months for any reasons except for adverse drug reaction
age 65 years old
Disqualifiers
with structural or vascular causes of dementia other than subcortical lacunes (2 or less) as seen in plain CT scan
dementia diagnosis other than AD as determined by an expert adult neurologist
with untreated depression or related psychiatric disorders in the last 6 months
use of systemic antibotics in the previous three months prior to providing fecal specimens
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AChE inhibitor monotherapy
DrugThis is a drug treatment using Donepezil only
AChE inhibitor and NMDA receptor antagonist combination therapy
DrugThis is a drug treatment combining Donepezil and Memantine
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Alzheimer's disease patients with AChE inhibitor monotherapy1 intervention
Group B: Alzheimer's disease patients given AChE inhibitor and NMDA receptor anatgonist combination therapy1 intervention
Trial outcomes
Primary outcomes
1
Change in gene signatures
Gene signatures obtained via whole exome sequencing
Time frame
Baseline, 3rd month, 6th month2
Change in gut microbiome metabolome signatures
Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling
Time frame
Baseline, 3rd month, 6th month3
Change in metabolome signatures
Metabolome signatures obtained via untargeted metabolomic profiling
Time frame
Baseline, 3rd month, 6th month4
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 monthSecondary outcomes
1
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 month2
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 month3
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 month4
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 monthSponsors and contacts
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Source ClinicalTrials.gov