Monitoring Drug Efficacy in Patients with Alzheimer's Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат AChE inhibitor monotherapy
  This is a drug treatment using Donepezil only
• Препарат AChE inhibitor and NMDA receptor antagonist combination therapy
  This is a drug treatment combining Donepezil and Memantine

Первичные конечные точки

• Change in gene signatures [Срок оценки: Baseline, 3rd month, 6th month]
• Change in gut microbiome metabolome signatures [Срок оценки: Baseline, 3rd month, 6th month]
• Change in metabolome signatures [Срок оценки: Baseline, 3rd month, 6th month]
• Change in levels of cognition using the Montreal Cognitive Assessment-Philippines (MoCA-P) [Срок оценки: Baseline, 3rd month, 6th month]
• Change in levels of cognition using the Mini-Mental State Examination (MMSE) [Срок оценки: Baseline, 3rd month, 6th month]
• Change in levels of cognition using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) [Срок оценки: Baseline, 3rd month, 6th month]

Вторичные конечные точки (5)

• Change in levels of functioning using the Katz Index of Activities of Daily Living (IADL) scale [Срок оценки: Baseline, 3rd month, 6th month]
• Change in levels of functioning using the Lawton instrumental activities of daily living (IADL) scale [Срок оценки: Baseline, 3rd month, 6th month]
• Changes in levels of behaviour using the Neuropsychiatric inventory (NPI) scale [Срок оценки: Baseline, 3rd month, 6th month]
• Change in levels of family functioning using the Filipino Family APGAR [Срок оценки: Baseline, 3rd month, 6th month]
• Change in levels of family functioning using the SCREEM Family Resources Survey (SCREEM-RES) [Срок оценки: Baseline, 3rd month, 6th month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Филиппины · 1 центр

• Philippine General Hospital — Manila

Публикации

• Climacosa FMM, Ornos EDB, Diwa ERS, Guantia MGR, Qureshi AP, Gapaz NCLL, Dacasin AB, Asis JLB, Carampel AC, Dela Cruz AM, Gordovez FJA, Reyes JCB, Tabios IKB, Manalo RVM, Cruz JMC, Anlacan VMM. Challenges in community-based recruitment of Alzheimer's disease cases: Experience of the monitoring drug efficacy through multi-omics research initiative in Alzheimer's disease (MEMORI-AD) study. J Alzheim PMID 41929959
• 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 metab PMID 39608999

Идентификаторы

NCT: NCT05801380 · SJREB-2022-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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