Investigating blood flow changes in dementia patients

Clarifying the Vascular Aspects of Dementia; Natural History Study

This study is trying to see how changes in blood flow relate to memory problems in people with different stages of dementia compared to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 1 site (Leiden)
• Trial ID: NCT06322121 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the natural progression of vascular reactivity (VR) in patients with subjective cognitive impairment (SCI), mild cognitive impairment (MCI), and Alzheimer's disease (AD) compared to healthy controls. Using blood oxygen level dependent (BOLD) MRI, the study will measure changes in VR, which has been identified as an early marker of cerebral amyloid angiopathy (CAA), a common co-morbidity in Alzheimer's. The goal is to determine how VR correlates with cognitive decline and disease severity over time, providing insights into the relationship between vascular health and dementia progression.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50-90 with subjective cognitive impairment, mild cognitive impairment, or Alzheimer's disease, as well as healthy adults without memory complaints.

Not a fit: Patients with contraindications to MRI scanning, such as those with pacemakers or severe claustrophobia, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and better management of dementia by identifying vascular changes associated with cognitive decline.

How similar studies have performed: Previous studies have indicated that measuring vascular reactivity can provide valuable insights into dementia progression, suggesting that this approach may yield meaningful results.

Eligibility criteria

Inclusion Criteria:

* For this study three different routes for inclusion exists. Inclusion criteria for each group separately are shown below.

  1. Participants who were included in our previous CASCADE study (P19.039).

     * Capable of giving informed consent (see appendix)
  2. Patients who attended a memory clinic within one year ago

     * Diagnosed with (mixed) probable AD
     * Diagnosed as MCI
     * Diagnosed as SCI
     * Age between 50-90 years
     * Capable of giving informed consent (see appendix)
  3. Control subjects

     * Healthy adults without memory complaints
     * Age between 50 -90 years
     * Capable of giving informed consent

Exclusion Criteria:

* Contra-indication to MRI scanning:

  * Claustrophobia
  * Pacemakers and defibrillators
  * Nerve stimulators
  * Intracranial clips
  * Intraorbital or intraocular metallic fragments
  * Cochlear implants
  * Ferromagnetic implants
  * Hydrocephaluspump
  * Intra-utrine device (not all types) Permanent make-up
  * Tattoos above the shoulders (not all)
* Specific contraindications to fMRI

  * Seizure within prior year.
  * Noncorrectable visual impairment.
* MMSE \< 19 points (measured at moment of screening or at memory clinic with a maximum of 6 months in retrospect)
* Severe physical restrictions (completely wheelchair dependent)
* Age above 90

Where this trial is running

Leiden

• Leids Universitair Medisch Centrum — Leiden, Netherlands (Recruiting)

Study contacts

• Study coordinator: Sanneke van Rooden, dr

Conditions Dementia