NCT04576793 Longitudinal Imaging of Microglial Activation in Different Clinical Variants of Alzheimer's Disease
| NCT ID | NCT04576793 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Patrick Lao |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-11-17 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2020-11-17 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine how inflammation is related to other changes in the brain that occur during the progression of Alzheimer's disease. The investigators are also studying how inflammation is related to the symptoms that first occur in patients with Alzheimer's disease (AD). For this reason, the investigators are asking people with different versions of Alzheimer's disease and/or other related dementias to participate. This includes patients with: * Mild Cognitive Impairment * Posterior cortical atrophy - a version of Alzheimer's disease with vision difficulties * Logopenic variant primary progressive aphasia - a version of Alzheimer's disease with language difficulties * Amnestic Alzheimer's disease - a "typical" version of Alzheimer's disease with memory difficulties * The investigators are also enrolling older adults with normal visual, language, and memory function.
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.
Contact & Investigator
Patrick J. Lao, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT04576793 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04576793 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04576793 currently recruiting?
Yes, NCT04576793 is actively recruiting participants. Contact the research team at as6545@cumc.columbia.edu for enrollment information.
Where is the NCT04576793 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT04576793 clinical trial?
NCT04576793 is sponsored by Patrick Lao. The principal investigator is Patrick J. Lao, PhD at Columbia University. The trial plans to enroll 100 participants.
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