Monitoring drug response in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the factors influencing drug response to acetylcholinesterase inhibitors and NMDA receptor antagonists in patients diagnosed with Alzheimer's Disease. Participants will be categorized based on their prescribed medications at baseline, and their treatment responses will be monitored over a period of six months. The study will include newly diagnosed patients who are treatment naive or have not taken specific medications in the last three months. The goal is to better understand how different therapies affect patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Philippine General Hospital
  Manila, National Capital Region, Philippines Recruiting

Study contacts

• Principal investigator: Fresthel Monica M Climacosa, MD, PhD — University of the Philippines Manila
• Study coordinator: Fresthel Monica M Climacosa, MD, PhD
• Email: fmclimacosa@up.edu.ph
• Phone: +639434744737

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.