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NCT05801380Recruiting

Monitoring Drug Efficacy in Patients with Alzheimer's Disease

Monitoring Drug Efficacy Through Multi-omics Research Initiative in Alzheimer's Disease

Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
10 Mar 2023
Start date
14 Feb 2022
Primary completion date
14 Feb 2026
Lead sponsor
University of the Philippines
NCT number
NCT05801380

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 14 Feb 2022 to the primary completion date, 14 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • use of systemic antibotics in the previous three months prior to providing fecal specimens
  • 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
  • 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

Other illness

  • 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 corticosteroids, immune stimulating medications, and immunosuppressive agents within the past 2 weeks or those who regularly need them for immune-related disorders
  • 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

Other

  • large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day)

Who the study is looking for

  • 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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Philippine General Hospital
Coordinator of this site? Confirm its status
ManilaPhilippinesRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.