Cognitive ImpairmentPNA1DB-DemNCT05484960
The Philippine Neurological Association One Database -Dementia
An observational study of Cognitive Impairment and Dementia, run by Philippine Neurological Association at 11 sites in Philippines.
Trial summary
This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients seen at the training institution for cognitive impairment diagnosed with Mild Cognitive Impairment (MCI) or Dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Dementia, Mild Cognitive Impairment
- What is being tested?
- cognitive assessment
- How many people
- 73 participants
- Where
- 11 sitesPhilippines
- Study dates
- 8 Dec 2021to 31 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients seen and evaluated at the participating sites are eligible to be included in the study if they fulfill all inclusion and none of the exclusion criteria.
Who may be able to join
- Patient with cognitive impairment diagnosed with Mild Cognitive Impairment or Dementia.
- 18 years old or older.
- Must be a Filipino Citizen.
- Seen and evaluated in the participating hospital by a neurologist.
- If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative.
Who cannot join
- Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Philippines11 sites, 11 recruiting
- Recruiting
Baguio General Hospital and Medical Center
Baguio City, Baguio
Debbie Liquete, MD, debzliquete1979@gmail.com
Debbie Liquete, MD
- Recruiting
Chong Hua Hospital
Cebu City, Cebu
Virginia Espanol, MD, virginiaespanol@gmail.com
Virginia Espanol, MD
- Recruiting
Makati Medical Center
Makati City, National Capital Region
Donnabelle Chu, MD, donnabelle.chu@gmail.com
Donnabelle Chu, MD
- Recruiting
Jose R. Reyes Memorial Medical Center
Manila, 1008
Joseree Catindig, MD, jscatindig@ust.edu.ph
Joseree Catindig
- Recruiting
University of Santo Tomas Hospiatl
Manila, 1008
Encarnita R Ampil, MD, (02)7313001, erampil@ust.edu.ph
Encarnita R Ampil, MD
- Recruiting
University of the East- Ramon Magsaysay Memorial Medical Center
Manila
Stephanie Badillo, MD, stephjordan.md@gmail.com
Stephanie Badillo, MD
- Not yet recruiting
University of the Philippines - Philippine General Hospital
Manila
Alvin Cenina, MD
afcenina@up.edu.ph
- Not yet recruiting
The Medical City
Pasig, National Capital Region
Grace Orteza, MD, GOOneuroconsult@gmail.com
Grace Orteza, MD
- Recruiting
East Avenue Medical Center
Quezon City, National Capital Region
Marissa Ong, MD, marissaong115@gmail.com
Marissa Ong, MD
- Recruiting
Quirino Memorial Medical Center
Quezon City, National Capital Region
Jemelle Cano, MD, jcano@stlukes.com.ph
Jemelle Cano, MD
- Not yet recruiting
St. Luke's Medical Center
Quezon City, National Capital Region
Jacqueline Dominguez, MD, jcdominguez@stlukes.com.ph
Jacqueline Dominguez, MD
About this study
Official title: Multicenter Collection of Uniform Data on Patients With Cognitive Impairment in the Philippines: the Philippine Neurological Association One Database -Dementia (PNA1DB-Dementia)
This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients seen at the training institution for cognitive impairment diagnosed with Mild Cognitive Impairment (MCI) or Dementia.
All patients seen at the training institution clinically diagnosed with MCI or dementia by their neurologists will be invited to participate in the study. The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool.
Read the detailed description
The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool. Patients who withdraw participation verbally or in writing are excluded by the investigator from further participation. Withdrawal from the study will be properly documented, including date, time, and reason for withdrawal. Withdrawn subjects will not have their clinical data included in the database.
Collective data will be extracted, summarized, and analyzed every year with oversight provided by the Philippine Neurological Association (PNA). To be able to assess trends and changes over time, data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed by the PNA.
- Conditions
- Cognitive Impairment, Dementia, Mild Cognitive Impairment
- Being tested
- cognitive assessment
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive assessmentOther
The clinical diagnosis will be made based on the criteria set by the investigators. Clinical history and bedside objective assessment in the form of Montreal Cognitive Assessment-Philippines (MoCA-P) or Mini Mental Status Examination-Philippines (MMSE-P), supported by a neuroimaging study (if neuroimaging is not done, diagnosis will be supported by the Hachinski Ischemic Score).
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of dementia and mild cognitive impairment in the study population
To determine the frequency of dementia and mild cognitive impairment in the study
Measured: on Day 1
Secondary outcomes (6)
F frequency of the different types of dementia in the study population
To determine the frequency of the different types of dementia in the study population using the clinical diagnosis
Measured: on Day 1
Frequency of risk factors for dementia in the study population
- determine the frequency of risk factors for dementia in the study population. (age, sex, educational attainment, family history, physical activity, smoking history, alcohol consumption, cardiovascular and cerebrovascular risk factors, chemical exposure, substance abuse, previous psychiatric condition and hearing impairment)
Measured: on Day 1
Demographic characteristics of patients with dementia or mild cognitive impairment
To describe the demographic characteristics of patients with dementia or mild cognitive impairment as to age at the time of diagnosis, age of onset of symptoms, sex, level of income (of patient or caregiver), location of clinic or hospital, current or previous occupation, educational attainment, neurologic exam findings
Measured: on Day 1
Dementia Severity
To categorize dementia severity in each subtype as mild, moderate and severe based on the initial MMSE score at the time of diagnosis.
Measured: on Day 1
Diagnostic tests used at the time of the diagnosis
To describe the types of diagnostic tests commonly done at the time of diagnosis, such as neuroimaging, blood tests, EEG
Measured: on Day 1
Pharmacologic and nonpharmacologic modalities used
To identify pharmacologic and nonpharmacologic modalities of treatment currently being used in the treatment of dementia
Measured: on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start8 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 73 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Philippine Neurological Association
- Sponsor type
- University, hospital or other
- Collaborators
- University of Santo Tomas Hospital, Philippines, Baguio General Hospital and Medical Center, Philippines, East Avenue Medical Center, Philippines, Jose R. Reyes Memorial Medical Center, Makati Medical Center, Quirino Memorial Medical Center, Philippines, St. Luke's Medical Center, Philippines, The Medical City, Philippines, University of the East- Ramon Magsaysay Memorial Medical Center, Philippines, University of the Philippines Manila - Philippine General Hospital, Chong Hua Hospital, Philippines
- Responsible party
- Sponsor
- Investigators
- Ma. Lourdes C Joson, MD, Principal investigator, Philippine Neurological Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484960
- Sponsor's protocol ID
- PNA2020_0X
- Acronym
- PNA1DB-Dem
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Collection of Uniform Data on Patients With Cognitive Impairment in the Philippines: the Philippine Neurological Association One Database -Dementia (PNA1DB-Dementia)
- ClinicalTrials.gov ID
- NCT05484960
- Acronym / sponsor ID
- PNA1DB-Dem / PNA2020_0X
- Conditions
- Cognitive Impairment, Dementia, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Philippine Neurological AssociationUniversity, hospital or other
- Collaborators
- University of Santo Tomas Hospital, Philippines, Baguio General Hospital and Medical Center, Philippines, East Avenue Medical Center, Philippines, Jose R. Reyes Memorial Medical Center, Makati Medical Center, Quirino Memorial Medical Center, Philippines, St. Luke's Medical Center, Philippines, The Medical City, Philippines, University of the East- Ramon Magsaysay Memorial Medical Center, Philippines, University of the Philippines Manila - Philippine General Hospital, Chong Hua Hospital, Philippines
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Aug 2022 (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 is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients seen at the training institution for cognitive impairment diagnosed with Mild Cognitive Impairment (MCI) or Dementia.
All patients seen at the training institution clinically diagnosed with MCI or dementia by their neurologists will be invited to participate in the study. The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool.
Detailed description
The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool. Patients who withdraw participation verbally or in writing are excluded by the investigator from further participation. Withdrawal from the study will be properly documented, including date, time, and reason for withdrawal. Withdrawn subjects will not have their clinical data included in the database.
Collective data will be extracted, summarized, and analyzed every year with oversight provided by the Philippine Neurological Association (PNA). To be able to assess trends and changes over time, data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed by the PNA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients seen and evaluated at the participating sites are eligible to be included in the study if they fulfill all inclusion and none of the exclusion criteria.
Key inclusion criteria (5 listed)
- Patient with cognitive impairment diagnosed with Mild Cognitive Impairment or Dementia.
- 18 years old or older.
- Must be a Filipino Citizen.
- Seen and evaluated in the participating hospital by a neurologist.
- If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative.
Key exclusion criteria (1 listed)
- Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results.
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 |
|---|---|---|
| cognitive assessmentThe clinical diagnosis will be made based on the criteria set by the investigators. Clinical history and bedside objective assessment in the form of Montreal Cognitive Assessment-Philippines (MoCA-P) or Mini Mental Status Examination-Philippines (MMSE-P), supported by a neuroimaging study (if neuroimaging is not done, diagnosis will be supported by the Hachinski Ischemic Score). | Other | – |
Primary outcome
Frequency of dementia and mild cognitive impairment in the study population
Time frame: on Day 1
To determine the frequency of dementia and mild cognitive impairment in the study
6 secondary outcomes
F frequency of the different types of dementia in the study population
Time frame: on Day 1
Frequency of risk factors for dementia in the study population
Time frame: on Day 1
Demographic characteristics of patients with dementia or mild cognitive impairment
Time frame: on Day 1
Dementia Severity
Time frame: on Day 1
Diagnostic tests used at the time of the diagnosis
Time frame: on Day 1
Pharmacologic and nonpharmacologic modalities used
Time frame: on Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No. To be available upon request
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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. This study is not recruiting at the moment.
Ma. Lourdes C Joson, MD principal investigator
Philippine Neurological Association
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Dementia, run by Philippine Neurological Association at 11 sites 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosalina Picar, MD ((02)87232102, repicarmd@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dementia and mild cognitive impairment in the study population (time frame: on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2022.