Imaging brain inflammation in Alzheimer's disease variants

Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease

This study is testing a new way to see how inflammation in the brain affects different types of Alzheimer's disease by using special scans and tests on participants over two years.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Columbia University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT04576793 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the relationship between inflammation and brain changes in various forms of Alzheimer's disease. Participants will undergo PET scans using an experimental drug to visualize inflammation, alongside lumbar punctures to analyze spinal fluid proteins and genetic testing. The study will track these changes over a two-year period to better understand the progression of Alzheimer's and its symptoms. By enrolling individuals with different clinical variants of Alzheimer's, the research seeks to uncover new treatment avenues.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50 and over with mild cognitive impairment or specific variants of Alzheimer's disease.

Not a fit: Patients with other brain disorders unrelated to Alzheimer's 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 with Alzheimer's disease.

How similar studies have performed: Other studies have shown promise in using imaging techniques to assess inflammation in Alzheimer's, but this specific approach is relatively novel.

Eligibility criteria

Inclusion criteria:

1. Age 50 and over at time of screening.
2. At screening, must have no cognitive impairment, or meet criteria for amnestic Alzheimer's disease, posterior cortical atrophy, or logopenic variant primary progressive aphasia. Diagnoses will be made based on history, exam, neuropsychological testing, brain MRI, and consensus diagnosis.
3. Patients must have Clinical Dementia Rating scale score of 0.5 or 1 at enrollment. Controls must have Clinical Dementia Rating scale score of 0 at enrollment.
4. Subjects unable to provide informed consent must have a surrogate decision maker.
5. Written and oral fluency in English or Spanish.
6. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
7. In the opinion of the PI, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion criteria:

1. Past or present history of a brain disorder other than Alzheimer's disease (including presence of cortical infarct on MRI even in absence of clinical stroke).
2. Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
3. Contraindication to MRI scanning.
4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
5. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
6. Exact medication exclusions are up to the discretion of the PI in consultation with the MD liaison.

Where this trial is running

New York, New York

• Columbia University Irving Medical Center — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Patrick J. Lao, PhD — Columbia University
• Study coordinator: Anna Smith

Conditions Alzheimer Disease; Inflammation; PET scans; Cognitive Impairment; Posterior Cortical Atrophy; Logopenic Variant Primary Progressive Aphasia; Amnestic Alzheimer's Disease; MK-6240