Monitoring Drug Efficacy in Patients with Alzheimer's Disease

NCT05801380 | Recruiting

• 1 other identifier: SJREB-2022-15
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

multiOMICs; drug response

Outcome Measures

Primary Outcomes (6)

• Change in gene signatures

  Gene signatures obtained via whole exome sequencing

  Baseline, 3rd month, 6th month

• Change in gut microbiome metabolome signatures

  Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling

  Baseline, 3rd month, 6th month

• Change in metabolome signatures

  Metabolome signatures obtained via untargeted metabolomic profiling

  Baseline, 3rd month, 6th month

• Change in levels of cognition using the Montreal Cognitive Assessment-Philippines (MoCA-P)

  Montreal Cognitive Assessment-Philippines (MoCA-P) is an assessment tool used to measure mild cognitive impairment and early Alzheimer's disease. Scores range from 0-30. A score below 21 signifies mild cognitive impairment or early Alzheimer's disease.

  Baseline, 3rd month, 6th month

• Change in levels of cognition using the Mini-Mental State Examination (MMSE)

  The Mini-Mental State Examination (MMSE) is an assessment tool used to measure cognitive aspects of mental functions, with scores ranging from 0-30, with lower scores indicating increasing levels of cognitive impairment.

  Baseline, 3rd month, 6th month

• Change in levels of cognition using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

  Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) assesses the severity of cognitive dysfunction in Alzheimer's Disease patients. Scores range from 0-94, with higher scores indicating increased levels of cognitive dysfunction.

  Baseline, 3rd month, 6th month

Secondary Outcomes (5)

• Change in levels of functioning using the Katz Index of Activities of Daily Living (IADL) scale

  Baseline, 3rd month, 6th month

• Change in levels of functioning using the Lawton instrumental activities of daily living (IADL) scale

  Baseline, 3rd month, 6th month

• Changes in levels of behaviour using the Neuropsychiatric inventory (NPI) scale

  Baseline, 3rd month, 6th month

• Change in levels of family functioning using the Filipino Family APGAR

  Baseline, 3rd month, 6th month

• Change in levels of family functioning using the SCREEM Family Resources Survey (SCREEM-RES)

  Baseline, 3rd month, 6th month

Study Arms (2)

Alzheimer's disease patients with AChE inhibitor monotherapy

This cohort includes those with the disease and given AChE inhibitor monotherapy only

Drug: AChE inhibitor monotherapy

Alzheimer's disease patients given AChE inhibitor and NMDA receptor anatgonist combination therapy

This cohort includes those with the disease, given AChE inhibitor and NMDA receptor antagonist combination therapy

Drug: AChE inhibitor and NMDA receptor antagonist combination therapy

Interventions

AChE inhibitor monotherapy DRUG

This is a drug treatment using Donepezil only

Also known as: Donepezil

Alzheimer's disease patients with AChE inhibitor monotherapy

AChE inhibitor and NMDA receptor antagonist combination therapy DRUG

This is a drug treatment combining Donepezil and Memantine

Also known as: Donepezil and Memantine combination therapy

Alzheimer's disease patients given AChE inhibitor and NMDA receptor anatgonist combination therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All elderly patients from (1) University of the Philippines - Philippine General Hospital; (2) The Medical City; and (3) Cardinal Santos Medical Center that meet the eligibility criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (1)

Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

RECRUITING

Related Publications (1)

• Climacosa FMM, Anlacan VMM, Gordovez FJA, Reyes JCB, Tabios IKB, Manalo RVM, Cruz JMC, Asis JLB, Razal RB, Abaca MJM, Dacasin AB, Espiritu APN, Gapaz NCLL, Lee Yu MHL. Monitoring drug Efficacy through Multi-Omics Research initiative in Alzheimer's Disease (MEMORI-AD): A protocol for a multisite exploratory prospective cohort study on the drug response-related clinical, genetic, microbial and metabolomic signatures in Filipino patients with Alzheimer's disease. BMJ Open. 2024 Nov 27;14(11):e078660. doi: 10.1136/bmjopen-2023-078660.

  PMID: 39608999 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. 10 mL of venous blood 2. Fecal specimen 3. 30 mL of urine

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Fresthel Monica M Climacosa, MD, PhD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

• Veeda Michelle M Anlacan, MD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fresthel Monica M Climacosa, MD, PhD

CONTACT

+639434744737; fmclimacosa@up.edu.ph

Veeda Michelle M Anlacan, MD

CONTACT

+639189197143; vmanlacan@up.edu.ph

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 6, 2023
• Study Start: February 14, 2022
• Primary Completion: February 14, 2026
• Study Completion: February 14, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)