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NCT Number: NCT05801380

Monitoring Drug Efficacy in Patients with Alzheimer's Disease

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

Location status: Recruiting

About this study

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

  • Alzheimer's Disease patients given AChE inhibitor monotherapy
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AChE inhibitor monotherapy

Drug

This is a drug treatment using Donepezil only

Other names: Donepezil

AChE inhibitor and NMDA receptor antagonist combination therapy

Drug

This is a drug treatment combining Donepezil and Memantine

Other names: Donepezil and Memantine combination therapy

Primary outcomes

  1. Change in gene signatures

    Time frame: Baseline, 3rd month, 6th month

    Gene signatures obtained via whole exome sequencing

  2. Change in gut microbiome metabolome signatures

    Time frame: Baseline, 3rd month, 6th month

    Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling

  3. Change in metabolome signatures

    Time frame: Baseline, 3rd month, 6th month

    Metabolome signatures obtained via untargeted metabolomic profiling

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

    Time frame: Baseline, 3rd month, 6th month

    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.

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

    Time frame: Baseline, 3rd month, 6th month

    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.

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

    Time frame: Baseline, 3rd month, 6th month

    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.

Secondary outcomes

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

    Time frame: Baseline, 3rd month, 6th month

    The Katz IADL assesses the patient's need for assistance in performing basic activities of daily living. Possible scores range from 0-12, with a higher score indicating better levels of functioning.

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

    Time frame: Baseline, 3rd month, 6th month

    The Lawton IADL assesses the patient's ability to carry out more complex tasks of daily living. Scores range from 0 indicating low function and dependent up to 16 indicating highly functional and independent.

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

    Time frame: Baseline, 3rd month, 6th month

    The neuropsychiatric inventory (NPI) scale is an informant-based interview that assesses neuropsychiatric symptoms in terms of frequency, severity, and levels of distress. Scores range from 0 to 144, with higher scores indicating the presence of more neuropsychiatric symptoms.

  4. Change in levels of family functioning using the Filipino Family APGAR

    Time frame: Baseline, 3rd month, 6th month

    Filipino family APGAR is a tool to assess family functioning based on five parameters: Adaptability, Partnership, Growth, Affection, and Resolve. The total scores range from 0 to 10 with higher scores indicating higher levels of satisfaction with family functioning.

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

    Time frame: Baseline, 3rd month, 6th month

    The SCREEM Family Resources Survey (SCREEM-RES) is a tool used to measure family resources that the family utilizes to cope with difficult situations. Scores range from 0 to 36, with higher scores indicating adequate levels of family resources.

Study contacts

Contact information is provided by the study sponsor or research team.

Fresthel Monica M Climacosa, MD, PhD

CONTACT

[email protected]

+639434744737

Veeda Michelle M Anlacan, MD

CONTACT

[email protected]

+639189197143

Sponsors and collaborators

Lead sponsor

University of the Philippines

Other

Registry information

Official study title

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

Acronym: MEMORI-AD

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2023
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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