The Philippine Neurological Association One Database -Dementia

Recruiting

• Conditions: Cognitive Impairment; Mild Cognitive Impairment; Dementia

• Registration Number: NCT05484960
• Lead Sponsor: Philippine Neurological Association

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 Withdrawn subjects will not have their clinical data included in the database.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.

Study Timeline

• Study Start: 2021-12-08
• Status Verified: 2022-07
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-07-31
• Last Update Submitted: 2022-07-31
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of dementia and mild cognitive impairment in the study population	on Day 1	To determine the frequency of dementia and mild cognitive impairment in the study

Secondary Outcome Measures

Name	Time	Method
Diagnostic tests used at the time of the diagnosis	on Day 1	To describe the types of diagnostic tests commonly done at the time of diagnosis, such as neuroimaging, blood tests, EEG
Demographic characteristics of patients with dementia or mild cognitive impairment	on Day 1	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
Dementia Severity	on Day 1	To categorize dementia severity in each subtype as mild, moderate and severe based on the initial MMSE score at the time of diagnosis.
Pharmacologic and nonpharmacologic modalities used	on Day 1	To identify pharmacologic and nonpharmacologic modalities of treatment currently being used in the treatment of dementia
F frequency of the different types of dementia in the study population	on Day 1	To determine the frequency of the different types of dementia in the study population using the clinical diagnosis
Frequency of risk factors for dementia in the study population	on Day 1	o 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)

Trial Locations

Locations (11)

The Medical City; 🇵🇭 Pasig City, Metro Manila, Philippines

Quirino Memorial Medical Center; 🇵🇭 Quezon City, Metro Manila, Philippines

East Avenue Medical Center; 🇵🇭 Quezon City, Metro Manila, Philippines

Chong Hua Hospital; 🇵🇭 Cebu City, Cebu, Philippines

Makati Medical Center; 🇵🇭 Makati City, Metro Manila, Philippines

Jose R. Reyes Memorial Medical Center; 🇵🇭 Manila, Philippines

University of Santo Tomas Hospiatl; 🇵🇭 Manila, Philippines

University of the East- Ramon Magsaysay Memorial Medical Center; 🇵🇭 Manila, Philippines

University of the Philippines - Philippine General Hospital; 🇵🇭 Manila, Philippines

St. Luke's Medical Center; 🇵🇭 Quezon City, Metro Manila, Philippines

Baguio General Hospital and Medical Center; 🇵🇭 Baguio City, Baguio, Philippines