Cognitive Impairment, Dementia, Mild Cognitive Impairment
Conditions
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 Withdrawn subjects will not have their clinical data included in the database.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.
Interventions
OTHERcognitive 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).
Sponsors
University of Santo Tomas Hospital, Philippines
Baguio General Hospital and Medical Center, 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 the East- Ramon Magsaysay Memorial Medical Center, Philippines
University of the Philippines Manila - Philippine General Hospital
Chong Hua Hospital, Philippines
Philippine Neurological Association
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Pharmacologic and nonpharmacologic modalities used | on Day 1 | To identify pharmacologic and nonpharmacologic modalities of treatment currently being used in the treatment of dementia |
| 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. |
| 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 |
Countries
Philippines
Contacts
Primary ContactRosalina Picar, MD
Outcome results
None listed