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Clinical Trials/NCT05484960
NCT05484960
Recruiting
Not Applicable

Multicenter Collection of Uniform Data on Patients With Cognitive Impairment in the Philippines: the Philippine Neurological Association One Database -Dementia (PNA1DB-Dementia)

Philippine Neurological Association11 sites in 1 country73 target enrollmentDecember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Impairment
Sponsor
Philippine Neurological Association
Enrollment
73
Locations
11
Primary Endpoint
Frequency of dementia and mild cognitive impairment in the study population
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 8, 2021
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Philippine Neurological Association
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Diagnostic tests used at the time of the diagnosis(on Day 1)
  • Demographic characteristics of patients with dementia or mild cognitive impairment(on Day 1)
  • Dementia Severity(on Day 1)
  • Pharmacologic and nonpharmacologic modalities used(on Day 1)
  • F frequency of the different types of dementia in the study population(on Day 1)
  • Frequency of risk factors for dementia in the study population(on Day 1)

Study Sites (11)

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