NCT05484960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

3.1 years

First QC Date

July 17, 2022

Last Update Submit

July 31, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • Demographic characteristics of patients with dementia or mild cognitive impairment

    on Day 1

  • Dementia Severity

    on Day 1

  • Diagnostic tests used at the time of the diagnosis

    on Day 1

  • +1 more secondary outcomes

Interventions

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).

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patient with cognitive impairment diagnosed with Mild Cognitive Impairment or Dementia.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Baguio General Hospital and Medical Center

Baguio City, Baguio, Philippines

RECRUITING

Chong Hua Hospital

Cebu City, Cebu, Philippines

RECRUITING

Makati Medical Center

Makati City, National Capital Region, Philippines

RECRUITING

The Medical City

Pasig, National Capital Region, Philippines

NOT YET RECRUITING

East Avenue Medical Center

Quezon City, National Capital Region, Philippines

RECRUITING

Quirino Memorial Medical Center

Quezon City, National Capital Region, Philippines

RECRUITING

St. Luke's Medical Center

Quezon City, National Capital Region, Philippines

NOT YET RECRUITING

Jose R. Reyes Memorial Medical Center

Manila, 1008, Philippines

RECRUITING

University of Santo Tomas Hospiatl

Manila, 1008, Philippines

RECRUITING

University of the East- Ramon Magsaysay Memorial Medical Center

Manila, Philippines

RECRUITING

University of the Philippines - Philippine General Hospital

Manila, Philippines

NOT YET RECRUITING

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Ma. Lourdes C Joson, MD

    Philippine Neurological Association

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalina Picar, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2022

First Posted

August 2, 2022

Study Start

December 8, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 2, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

To be available upon request

Locations