Clinical trial NCT05484960: The Philippine Neurological Association One Database -Dementia
Official title: Multicenter Collection of Uniform Data on Patients With Cognitive Impairment in the Philippines: the Philippine Neurological Association One Database -Dementia (PNA1DB-Dementia)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Impairment
Dementia
Mild Cognitive Impairment
Lead sponsor: Philippine Neurological Association
Sponsor class: OTHER
Collaborators: name: University of Santo Tomas Hospital, Philippines
name: Baguio General Hospital and Medical Center, Philippines
name: East Avenue Medical Center, Philippines
name: Jose R. Reyes Memorial Medical Center
name: Makati Medical Center
name: Quirino Memorial Medical Center, Philippines
name: St. Luke's Medical Center, Philippines
name: The Medical City, Philippines
name: University of the East- Ramon Magsaysay Memorial Medical Center, Philippines
name: University of the Philippines Manila - Philippine General Hospital
name: Chong Hua Hospital, Philippines
First posted: 2022-08-02
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria

• 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.

Primary outcomes:
measure: Frequency of dementia and mild cognitive impairment in the study population
timeFrame: on Day 1
Secondary outcomes:
measure: F frequency of the different types of dementia in the study population
timeFrame: on Day 1
measure: Frequency of risk factors for dementia in the study population
timeFrame: on Day 1
measure: Demographic characteristics of patients with dementia or mild cognitive impairment
timeFrame: on Day 1
measure: Dementia Severity
timeFrame: on Day 1
measure: Diagnostic tests used at the time of the diagnosis
timeFrame: on Day 1
measure: Pharmacologic and nonpharmacologic modalities used
timeFrame: on Day 1
Other outcomes:
Locations:
city: Baguio City
country: Philippines
facility: Baguio General Hospital and Medical Center
state: Baguio
city: Cebu City
country: Philippines
facility: Chong Hua Hospital
state: Cebu
city: Makati City
country: Philippines
facility: Makati Medical Center
state: Metro Manila
city: Pasig City
country: Philippines
facility: The Medical City
state: Metro Manila
city: Quezon City
country: Philippines
facility: East Avenue Medical Center
state: Metro Manila
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center
state: Metro Manila
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: Metro Manila
city: Manila
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: University of Santo Tomas Hospiatl
city: Manila
country: Philippines
facility: University of the East- Ramon Magsaysay Memorial Medical Center
city: Manila
country: Philippines
facility: University of the Philippines - Philippine General Hospital
Study officials:
affiliation: Philippine Neurological Association
name: Ma. Lourdes C Joson, MD
role: PRINCIPAL_INVESTIGATOR
References: