RecruitingNCT05801380

Monitoring Drug Efficacy in Patients with Alzheimer's Disease

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

Sponsor

University of the Philippines

Enrollment

60 participants

Start Date

Feb 14, 2022

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease

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

Min Age: 65 Years

Inclusion Criteria6

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 Criteria11

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