Monitoring Drug Effects Using Multi-omics Research in Alzheimer's Disease
Observational Study of Donepezil and Memantine Treatments
Led by University of the Philippines · Updated on 2025-01-07
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
Published Results
AI-Summary
What this Trial Is About
Researchers are investigating how different factors influence the response to two types of drug treatments—acetylcholinesterase (AChE) inhibitor donepezil and NMDA receptor antagonist memantine—in patients with Alzheimer's Disease. The study aims to monitor changes in gene signatures, gut microbiome metabolome, other metabolome signatures, and cognitive function over six months using various cognitive assessments.
Participants will be divided into two groups based on the medication prescribed by their attending physician: one group receiving donepezil alone (AChE inhibitor monotherapy) and another group receiving a combination of donepezil and memantine (AChE inhibitor and NMDA receptor antagonist combination therapy). These treatments will be observed at baseline, 3 months, and 6 months to assess their effects on the patients.
During the study, participants will undergo evaluations of gene expression, metabolome changes, and cognitive tests including the Montreal Cognitive Assessment-Philippines (MoCA-P), Mini-Mental State Examination (MMSE), and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) at baseline, 3 months, and 6 months. Researchers will track treatment response and monitor safety throughout the 6-month follow-up period.
CONDITIONS
Official Title
Monitoring Drug Efficacy in Patients with Alzheimer's Disease
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
Newly diagnosed with mild or moderate dementia using the Montreal Cognitive Assessment and Clinical Dementia Rating performed by a licensed psychometrician
Clinically diagnosed by an expert adult neurologist as having probable Alzheimer's Disease using NINCDS-ADRDA criteria
Treatment naive for acetylcholinesterase inhibitors or memantine, or not taken these drugs in the last 3 months except for adverse drug reaction
Age 65 years old or older
Residing in the National Capital Region
Able to read and understand written and spoken English and Filipino
You will not qualify if you...
Structural or vascular causes of dementia other than subcortical lacunes (2 or less) seen in plain CT scan
Dementia diagnosis other than Alzheimer's Disease as determined by an expert neurologist
Untreated depression or related psychiatric disorders in the last 6 months
Use of systemic antibiotics in the previous 3 months before providing fecal specimens
Use of corticosteroids, immune stimulating medications, or immunosuppressive agents within past 2 weeks or regularly for immune disorders
Use of proton-pump inhibitors, H2-receptor antagonists, tricyclic antidepressants, narcotics, anticholinergic medications, laxatives, or anti-diarrheal in past 4 weeks
Consumption of large doses of commercial probiotics (≥108 cfu per day)
Major dietary change during previous month
Major gastrointestinal surgery in past 5 years except cholecystectomy and appendectomy
Major bowel resection at any time
Active uncontrolled gastrointestinal disorders or diseases including inflammatory bowel disease, indeterminate colitis, irritable bowel syndrome, persistent infectious gastroenteritis, colitis or gastritis, chronic diarrhea of unknown cause, recurrent Clostridium difficile infection, untreated Helicobacter pylori infection, chronic constipation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Philippine General Hospital
Manila, National Capital Region, Philippines, 1000
Actively Recruiting
Loading map...
Research Team
F
Fresthel Monica M Climacosa, MD, PhD
V
Veeda Michelle M Anlacan, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Challenges in community-based recruitment of Alzheimer's disease cases: Experience of the monitoring drug efficacy through multi-omics research initiative in Alzheimer's disease (MEMORI-AD) study.
Fresthel Monica M Climacosa, Eric David B Ornos, Erwin Rommel S Diwa...
Monitoring drug Efficacy through Multi-Omics Research initiative in Alzheimer's Disease (MEMORI-AD): A protocol for a multisite exploratory prospective cohort study on the drug response-related clinical, genetic, microbial and metabolomic signatures in Filipino patients with Alzheimer's disease.
Fresthel Monica M Climacosa, Veeda Michelle M Anlacan, Francis James A Gordovez...
