Recruiting
Phase 2

Alzheimer's Disease

Sponsor:

Columbia University

Code:

NCT04576793

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

11C-ER176

18F-MK6240

18F-Florbetaben

Lumbar Puncture

Study Details

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.

Conditions

Alzheimer Disease

Study ID

NCT04576793

Start date

Nov 17, 2020

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cognitive impairment

  • 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

active comparator: No cognitive impairment

Healthy controls

Interventions

11C-ER176

11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. 11C-ER176 will be administered at activity up to 20 millicurie (mCi) per injection.

18F-MK6240

MK-6240 measures a protein called in the brain. MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.

18F-Florbetaben

Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. florbetaben measures amyloid in the brain.

Lumbar Puncture

Inflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators will perform a lumbar puncture (spinal tap).

Primary outcome measure

  • 11C-ER176 Standardized Uptake Value Ratio [ Time Frame: Up to 24 months ]
  • 18F-MK6240 Standardized Uptake Value Ratio [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

More Information

Sponsor

Columbia University

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-07-06.