Alzheimer DiseaseMEMORI-ADNCT05801380
Monitoring Drug Efficacy in Patients with Alzheimer's Disease
An observational study of Alzheimer Disease, run by University of the Philippines at 1 site in Philippines.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AChE inhibitor monotherapy and AChE inhibitor and NMDA receptor antagonist combination therapy
- How many people
- 60 participants
- Where
- 1 sitePhilippines
- Study dates
- 14 Feb 2022to 14 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines1 site, 1 recruiting
- Recruiting
Philippine General Hospital
Manila, National Capital Region, 1000
About this study
Official title: Monitoring Drug Efficacy Through Multi-omics Research Initiative in 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.
Read the detailed 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:
- 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.
- Conditions
- Alzheimer Disease
- Being tested
- AChE inhibitor monotherapy, AChE inhibitor and NMDA receptor antagonist combination therapy
- Keywords
- multiOMICs, drug response
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AChE inhibitor monotherapyDrug
Also called Donepezil
This is a drug treatment using Donepezil only
AChE inhibitor and NMDA receptor antagonist combination therapyDrug
Also called Donepezil and Memantine combination therapy
This is a drug treatment combining Donepezil and Memantine
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's disease patients with AChE inhibitor monotherapy | This cohort includes those with the disease and given AChE inhibitor monotherapy only Receives: 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 Receives: Drug: AChE inhibitor and NMDA receptor antagonist combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gene signatures
Gene signatures obtained via whole exome sequencing
Measured: Baseline, 3rd month, 6th month
Change in gut microbiome metabolome signatures
Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling
Measured: Baseline, 3rd month, 6th month
Change in metabolome signatures
Metabolome signatures obtained via untargeted metabolomic profiling
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3rd month, 6th month
Secondary outcomes (5)
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.
Measured: Baseline, 3rd month, 6th month
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.
Measured: Baseline, 3rd month, 6th month
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.
Measured: Baseline, 3rd month, 6th month
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.
Measured: Baseline, 3rd month, 6th month
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.
Measured: Baseline, 3rd month, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start14 Feb 2022
- Primary completion14 Feb 2026 (estimated)
- Study completion14 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fresthel Monica Climacosa, University of the Philippines
- Investigators
- Fresthel Monica M Climacosa, MD, PhD, Principal investigator, University of the Philippines ManilaVeeda Michelle M Anlacan, MD, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801380
- Sponsor's protocol ID
- SJREB-2022-15
- Acronym
- MEMORI-AD
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Alzheimers Dis Rep. 2026 Mar 9;10:25424823261431318. doi: 10.1177/25424823261431318. eCollection 2026 Jan-Dec.
PubMed 41929959Climacosa 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.
PubMed 39608999
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Drug Efficacy Through Multi-omics Research Initiative in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05801380
- Acronym / sponsor ID
- MEMORI-AD / SJREB-2022-15
- Conditions
- Alzheimer Disease
- Keywords
- multiOMICs, drug response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 14 Feb 2026 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's disease patients with AChE inhibitor monotherapy | – | Drug: AChE inhibitor monotherapyThis cohort includes those with the disease and given AChE inhibitor monotherapy only |
| Alzheimer's disease patients given AChE inhibitor and NMDA receptor anatgonist combination therapy | – | Drug: AChE inhibitor and NMDA receptor antagonist combination therapyThis cohort includes those with the disease, given AChE inhibitor and NMDA receptor antagonist combination therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AChE inhibitor monotherapyAlso: DonepezilThis is a drug treatment using Donepezil only | Drug | Alzheimer's disease patients with AChE inhibitor monotherapy |
| AChE inhibitor and NMDA receptor antagonist combination therapyAlso: Donepezil and Memantine combination therapyThis is a drug treatment combining Donepezil and Memantine | Drug | Alzheimer's disease patients given AChE inhibitor and NMDA receptor anatgonist combination therapy |
Primary outcome
Change in gene signatures
Time frame: Baseline, 3rd month, 6th month
Gene signatures obtained via whole exome sequencing
Change in gut microbiome metabolome signatures
Time frame: Baseline, 3rd month, 6th month
Gut microbiome signatures obtained via gut microbiome shotgun metagenomic profiling
Change in metabolome signatures
Time frame: 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)
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.
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.
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.
5 secondary outcomes
Change in levels of functioning using the Katz Index of Activities of Daily Living (IADL) scale
Time frame: Baseline, 3rd month, 6th month
Change in levels of functioning using the Lawton instrumental activities of daily living (IADL) scale
Time frame: Baseline, 3rd month, 6th month
Changes in levels of behaviour using the Neuropsychiatric inventory (NPI) scale
Time frame: Baseline, 3rd month, 6th month
Change in levels of family functioning using the Filipino Family APGAR
Time frame: Baseline, 3rd month, 6th month
Change in levels of family functioning using the SCREEM Family Resources Survey (SCREEM-RES)
Time frame: Baseline, 3rd month, 6th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Derived from this study: PubMed 41929959Climacosa 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 Alzheimers Dis Rep. 2026 Mar 9;10:25424823261431318. doi: 10.1177/25424823261431318. eCollection 2026 Jan-Dec.
- Derived from this study: PubMed 39608999Climacosa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fresthel Monica M Climacosa, MD, PhD principal investigator
University of the Philippines Manila
Veeda Michelle M Anlacan, MD principal investigator
University of the Philippines Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by University of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fresthel Monica M Climacosa, MD, PhD (+639434744737, fmclimacosa@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gene signatures (time frame: Baseline, 3rd month, 6th month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05801380, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.