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The Philippine Neurological Association One Database -Dementia (PNA1DB-Dem)

P

Philippine Neurological Association

Status

Enrolling

Conditions

Cognitive Impairment
Mild Cognitive Impairment
Dementia

Treatments

Other: cognitive assessment

Study type

Observational

Funder types

Other

Identifiers

NCT05484960
PNA2020_0X

Details and patient eligibility

About

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.

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 Withdrawn subjects will not have their clinical data included in the database.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

Enrollment

73 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

11

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Central trial contact

Rosalina Picar, MD

Data sourced from clinicaltrials.gov

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