Investigating the role of vascular injury and proteins in cognitive impairment and dementia

The Influence of Vascular Burden, Amyloid Plaque and Tau Protein in Patients With Vascular Cognitive Impairment and Dementia With Tauopathy

This study is trying to see how blood vessel damage and certain proteins affect thinking problems in people with different types of dementia, including Alzheimer's disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Locations: 1 site (Taoyuan, Guishan)
• Trial ID: NCT04309253 on ClinicalTrials.gov

What this trial studies

This study aims to explore the relationship between vascular cognitive impairment, amyloid plaques, and tau proteins in patients with various forms of dementia, including Alzheimer's disease and fronto-temporal dementia. Utilizing advanced neuroimaging techniques, the research will recruit patients across three groups: those with vascular cognitive impairment, Alzheimer's disease/mild cognitive impairment, and fronto-temporal dementia. The study will assess how these factors contribute to cognitive decline, providing insights into the complex interactions between vascular injury and neurodegeneration. Participants will receive specific interventions aimed at understanding these dynamics.

Who should consider this trial

Good fit: Ideal candidates include adults aged 20 and older diagnosed with vascular cognitive impairment, Alzheimer's disease/mild cognitive impairment, or fronto-temporal dementia.

Not a fit: Patients without a diagnosis of vascular cognitive impairment, Alzheimer's disease, or fronto-temporal dementia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from cognitive impairments related to vascular issues and neurodegenerative diseases.

How similar studies have performed: Other studies have shown promise in exploring the interactions between vascular factors and neurodegeneration, but this specific approach using novel radiotracers is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Inclusion criteria for VCI (Group A, n=80)

   * Males or females with age \>= 20 years old.
   * Patients fulfill the AHA/ASA criteria for vascular cognitive impairment.
   * Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable).
   * The subject has an appropriate caregiver capable of accompanying the subject, if necessary.
2. Inclusion criteria for AD / MCI (Group B, n=120)

   * Males or females with age \>= 20 years old.
   * Patients fulfill the National Institute on Aging (NIA) - Alzheimer's Association Diagnostic Guidelines.
   * Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable).
   * The subject has an appropriate caregiver capable of accompanying the subject, if necessary.
3. Inclusion criteria for FTD (Group C, n=30)

   * Males or females with age \>= 20 years old.
   * Patients fulfill the criteria of probable FTD.
   * Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable).
   * The subject has an appropriate caregiver capable of accompanying the subject, if necessary.
4. Inclusion criteria for normal control (Group D, n=30)

   * Males or females with age \>= 20 years old.
   * Provision of signed informed consent.
5. Inclusion criteria for PSP (Group E, n=80)

   * Males or females with age \>= 20 years old
   * Patients fulfill the 2017 Movement Disorder Society criteria of PSP.
   * Provision of signed informed consent from the subject and the subject's legally authorized representative or caregiver (if applicable)
   * The subject has an appropriate caregiver capable of accompanying the subject, if necessary.

Exclusion Criteria:

* Life expectancy less than 1 year.
* Clinically significant abnormal laboratory values (such as AST/ALT \>= 3X of upper normal limits).
* Clinically significant or unstable medical or psychiatric illness.
* Epilepsy history.
* Cognitive impairment resulting from trauma or brain damage.
* Substance abuse or alcoholism in the past 3 months.
* Stroke history within the recent 3 months.

Where this trial is running

Taoyuan, Guishan

• Department of Neurology, Chang-Gung memorial Hospital — Taoyuan, Guishan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Huang Kuo-Lun, M.D.

Conditions Vascular Cognitive Impairment, Alzheimer's Disease, Fronto-temporal Dementia; Vascular cognitive impairment, Alzheimer's disease, fronto-temporal dementia, amyloid plaque, tau protein