Monitoring Drug Efficacy Through Multi-omics Research Initiative in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in gene signatures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Alzheimer's disease patients with AChE inhibitor monotherapy
This cohort includes those with the disease and given AChE inhibitor monotherapy only
干预措施: AChE inhibitor monotherapy (Drug)
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
干预措施: AChE inhibitor and NMDA receptor antagonist combination therapy (Drug)
结局指标
主要结局
Change in gene signatures
时间窗: Baseline, 3rd month, 6th month
Gene signatures obtained via whole exome sequencing
Change in gut microbiome metabolome signatures
时间窗: Baseline, 3rd month, 6th month
Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling
Change in metabolome signatures
时间窗: Baseline, 3rd month, 6th month
Metabolome signatures obtained via untargeted metabolomic profiling
Change in levels of cognition using the Montreal Cognitive Assessment-Philippines (MoCA-P)
时间窗: 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.
Change in levels of cognition using the Mini-Mental State Examination (MMSE)
时间窗: 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.
Change in levels of cognition using the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
时间窗: 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.
次要结局
- 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 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)
- Change in levels of family functioning using the SCREEM Family Resources Survey (SCREEM-RES)(Baseline, 3rd month, 6th month)
研究者
Fresthel Monica Climacosa
Associate Professor
University of the Philippines