Monitoring Drug Efficacy in Patients with Alzheimer's Disease

Last updated: January 5, 2025
Sponsor: University of the Philippines
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

AChE inhibitor monotherapy

AChE inhibitor and NMDA receptor antagonist combination therapy

Clinical Study ID

NCT05801380
SJREB-2022-15
  • Ages > 65
  • All Genders

Study 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

Inclusion Criteria:

  • newly diagnosed with mild or moderate dementia using the Montreal CognitiveAssessment and Clinical Dementia Rating (CDR) performed by a licensedpsychometrician

  • clinically diagnosed by an expert adult neurologist as having probable AD using theNational Institute of Neurological and Communicative Disorders and Stroke andAlzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

  • treatment naive for any acetylcholinesterase inhibitors or memantine OR those whohave not taken any acetylcholinesterase inhibitors or memantine in the last threemonths 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

Exclusion Criteria:

  • with structural or vascular causes of dementia other than subcortical lacunes (2 orless) 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 fecalspecimens

  • use of corticosteroids, immune stimulating medications, and immunosuppressive agentswithin the past 2 weeks or those who regularly need them for immune-relateddisorders

  • use of proton-pump inhibitors, H2-receptor antagonists, H2-receptor antagonists,tricyclic antidepressants, narcotics, anticholinergic medications, laxatives oranti-diarrheal in the past 4 weeks

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

  • major dietary change during previous month (defined as eliminating or significantlyincreasing a major food group)

  • major GI tract surgery in the past 5 years, with the exception of cholecystectomyand appendectomy

  • major bowel resection at any time

  • active uncontrolled GI disorders or diseases, including inflammatory bowel disease,indeterminate colitis, irritable bowel syndrome, persistent infectiousgastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknownetiology, recurrent Clostridium difficile infection, untreated Helicobacter pyloriinfection, chronic constipation

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: AChE inhibitor monotherapy
Phase:
Study Start date:
February 14, 2022
Estimated Completion Date:
February 14, 2026

Study Description

These patients will be grouped according to the medications prescribed by their attending physician at baseline, 3rd month, and 6th month of follow up:

  1. Alzheimer's Disease patients given AChE inhibitor monotherapy

  2. Alzheimer's Disease patients given combination therapy of AChE inhibitor and NMDA receptor antagonist

They will be observed for treatment response for up to 6 months.

Connect with a study center

  • Philippine General Hospital

    Manila, Metro Manila 1000
    Philippines

    Active - Recruiting

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