The Philippine Neurological Association One Database -Dementia

Dementia Clinical Trial

— PNA1DB-Dem  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05484960
• Other study ID #: PNA2020_0X
• Status: Recruiting
• Start date: December 8, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Philippine Neurological Association
• Contact: Rosalina Picar, MD
• Phone: (02)87232102
• Email: repicarmd[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Mild Cognitive Impairment

Intervention

Other:
• cognitive assessment
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).

Locations

Country	Name	City	State
Philippines	Baguio General Hospital and Medical Center	Baguio City	Baguio
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	The Medical City	Pasig City	Metro Manila
Philippines	East Avenue Medical Center	Quezon City	Metro Manila
Philippines	Quirino Memorial Medical Center	Quezon City	Metro Manila
Philippines	St. Luke's Medical Center	Quezon City	Metro Manila

Sponsors (12)

Lead Sponsor

Collaborator

Philippine Neurological Association

Baguio General Hospital and Medical Center, Philippines, Chong Hua Hospital, 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 Santo Tomas Hospital, Philippines, University of the East- Ramon Magsaysay Memorial Medical Center, Philippines, University of the Philippines Manila - Philippine General Hospital

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of dementia and mild cognitive impairment in the study population	To determine the frequency of dementia and mild cognitive impairment in the study	on Day 1
Secondary	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	on Day 1
Secondary	Frequency of risk factors for dementia in the study population	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)	on Day 1
Secondary	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	on Day 1
Secondary	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.	on Day 1
Secondary	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	on Day 1
Secondary	Pharmacologic and nonpharmacologic modalities used	To identify pharmacologic and nonpharmacologic modalities of treatment currently being used in the treatment of dementia	on Day 1