NCT05801380 Monitoring Drug Efficacy in Patients with Alzheimer's Disease
| NCT ID | NCT05801380 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of the Philippines |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-02-14 |
| Primary Completion | 2026-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-02-14 with a primary completion date of 2026-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * residing in the National Capital Region * able to read and understand written and spoken English and Filipino Exclusion Criteria: * 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 * use of corticosteroids, immune stimulating medications, and immunosuppressive agents within the past 2 weeks or those who regularly need them for immune-related disorders * use of proton-pump inhibitors, H2-receptor antagonists, H2-receptor antagonists, tricyclic antidepressants, narcotics, anticholinergic medications, laxatives or anti-diarrheal in the past 4 weeks * large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) * major dietary change during previous month (defined as eliminating or significantly increasing a major food group) * major GI tract surgery in the past 5 years, with the exception of cholecystectomy and appendectomy * major bowel resection at any time * active uncontrolled GI disorders or diseases, including inflammatory bowel disease, indeterminate colitis, irritable bowel syndrome, persistent infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, recurrent Clostridium difficile infection, untreated Helicobacter pylori infection, chronic constipation
Contact & Investigator
Fresthel Monica M Climacosa, MD, PhD
PRINCIPAL INVESTIGATOR
University of the Philippines Manila
Frequently Asked Questions
Who can join the NCT05801380 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05801380 currently recruiting?
Yes, NCT05801380 is actively recruiting participants. Contact the research team at fmclimacosa@up.edu.ph for enrollment information.
Where is the NCT05801380 trial being conducted?
This trial is being conducted at Manila, Philippines.
Who is sponsoring the NCT05801380 clinical trial?
NCT05801380 is sponsored by University of the Philippines. The principal investigator is Fresthel Monica M Climacosa, MD, PhD at University of the Philippines Manila. The trial plans to enroll 60 participants.
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