Monitoring Drug Efficacy in Patients With Alzheimer's Disease

Alzheimer Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801380
• Other study ID #: SJREB-2022-15
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: February 14, 2025

Study information

• Verified date: March 2023
• Source: University of the Philippines
• Contact: Fresthel Monica M Climacosa, MD, PhD
• Phone: +639434744737
• Email: fmclimacosa[@]up.edu.ph
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 14, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
Philippines	Philippine General Hospital	Manila	Metro Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gene signatures	Gene signatures obtained via whole exome sequencing	Baseline, 3rd month, 6th month
Primary	Change in gut microbiome metabolome signatures	Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling	Baseline, 3rd month, 6th month
Primary	Change in metabolome signatures	Metabolome signatures obtained via untargeted metabolomic profiling	Baseline, 3rd month, 6th month
Primary	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
Primary	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
Primary	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	Change in levels of functioning using the Katz Index of Activities of Daily Living (IADL) scale	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.	Baseline, 3rd month, 6th month
Secondary	Change in levels of functioning using the Lawton instrumental activities of daily living (IADL) scale	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.	Baseline, 3rd month, 6th month
Secondary	Changes in levels of behaviour using the Neuropsychiatric inventory (NPI) scale	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.	Baseline, 3rd month, 6th month
Secondary	Change in levels of family functioning using the Filipino Family APGAR	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.	Baseline, 3rd month, 6th month
Secondary	Change in levels of family functioning using the SCREEM Family Resources Survey (SCREEM-RES)	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.	Baseline, 3rd month, 6th month