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CompletedNCT03373604Updated May 8, 2025Results posted

Imaging Tau in Alzheimer's Disease and Normal Aging

A Phase 2 interventional study of 18F-MK-6240 and Lumbar Puncture (optional) in Alzheimer Disease, sponsored by Patrick Lao. Completed at 1 site in United States. Open to participants aged 50 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-08.

Sponsored by Patrick Lao · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
71
Allocation
Non-randomized
Ages
50 Years to 100 Years
Sex
All
01

Study summary

This study is being done to learn about tau tangles in Alzheimer's disease. A type of positron emission tomography (PET) scan is used to measure the abnormal accumulation of protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and to tests to measure the participant's memory and thinking.

Read the detailed description

This study is being done to determine the relationship between tau tangles and cognitive impairment in elderly subjects with and without Alzheimer's disease (AD). Subjects will undergo screen that includes neuropsychological testing and brain MRI. This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special radioactive dye called 18F-MK-6240 is injected into the body. 18F-MK-6240 sticks to abnormal tangles made of the protein tau. Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of biomarkers.

02

Conditions studied

  • Alzheimer Disease

Browse trials for

Keywords

  • 18F-MK-6240
  • Cognitive Impairment
  • Alzheimer's
03

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 50 and older.

  2. Meet criteria for either

    1. amnestic mild cognitive impairment (MCI) (single or mixed domain) or mild Alzheimer's disease (AD), or
    2. have no cognitive impairment, based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
  3. Subjects unable to provide informed consent must have a surrogate decision maker.
  4. Written and oral fluency in English or Spanish.
  5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
  6. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion criteria

Exclusion Criteria:

  1. Past or present history of certain brain disorders other than MCI or AD.
  2. Certain significant 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 magnetic resonance imaging (MRI) scanning.
  4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
  5. History of kidney disease or presence of impaired kidney function based on laboratory tests at screening visit.
  6. History of liver disease or presence of impaired liver function based on laboratory tests at screening visit.
  7. Participation in the last year in a clinical trial for a disease modifying drug for AD.
  8. Inability to have a catheter in subject's vein for the injection of radioligand.
  9. Inability to have blood drawn from subject's veins.
04

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Cognitive impairment

    Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)

    Drug: 18F-MK-6240 · Procedure: Lumbar Puncture (optional)

  • Active comparator
    No cognitive impairment

    Healthy controls

    Drug: 18F-MK-6240 · Procedure: Lumbar Puncture (optional)

Interventions

  • Drug18F-MK-6240

    18F-MK-6240 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.

    Also known as: [18F]-MK6240

  • ProcedureLumbar Puncture (optional)

    Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.

05

What researchers measure

Primary outcomes

  1. 18F-MK-6240 Binding

    Standardized uptake value ratio (SUVr)

    Time frame: 1 day

Secondary outcomes

  1. Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.

    Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation.

    Time frame: One year follow-up

06

Results

Posted May 8, 2025

Participant flow

Participant flow — Overall Study
MilestoneNo Cognitive ImpairmentCognitive Impairment
Started4328
Completed4328
Not completed00

Outcome measures

Primary18F-MK-6240 Binding

Standardized uptake value ratio (SUVr)

Time frame:
1 day
Reported as:
Mean · SUVr
18F-MK-6240 Binding
SUVrNo Cognitive ImpairmentCognitive Impairment
18F-MK-6240 Binding1.41 ± 0.432.30 ± 0.92
SecondaryCorrelation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.

Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation.

Time frame:
One year follow-up
Reported as:
Number · correlation coefficient (r)
Correlation Between Tau, Neurodegeneration and Inflammation Using PET and CSF Biomarkers.
correlation coefficient (r)No Cognitive ImpairmentCognitive Impairment
Correlation between Tau and Neurodegeneration-0.3470.013
Correlation between Tau and Inflammation-0.2950.181

Adverse events

Collected over During the scanning procedure (1 day), and at 1 year follow-up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
No Cognitive Impairment0/43 (0%)0/43 (0%)4/43 (9.3%)
Cognitive Impairment0/28 (0%)0/28 (0%)4/28 (14.3%)
Most frequent other events
Most frequent other events
EventNo Cognitive ImpairmentCognitive Impairment
Sore arm from IV placementInjury, poisoning and procedural complications0/431/28
Elevated blood pressureBlood and lymphatic system disorders1/431/28
musculoskeletal painMusculoskeletal and connective tissue disorders0/431/28
FallInjury, poisoning and procedural complications0/431/28
hypoglycemiaBlood and lymphatic system disorders1/430/28
Chest painGeneral disorders1/430/28
lightheadednessGeneral disorders1/430/28

Baseline characteristics

Age, Continuous
Age, Continuous(years)No Cognitive ImpairmentCognitive ImpairmentTotal
Mean70.6 ± 8.669.5 ± 10.270.1 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)No Cognitive ImpairmentCognitive ImpairmentTotal
Female21728
Male222143
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)No Cognitive ImpairmentCognitive ImpairmentTotal
Hispanic or Latino325
Not Hispanic or Latino402666
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)No Cognitive ImpairmentCognitive ImpairmentTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American16218
White272653
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)No Cognitive ImpairmentCognitive ImpairmentTotal
United States432871
07

Study locations

1 site
  • Columbia University Medical Center
    New York, New York 10032, United States
08

References and documents

Publications

  • Klein J, Yan X, Johnson A, Tomljanovic Z, Zou J, Polly K, Honig LS, Brickman AM, Stern Y, Devanand DP, Lee S, Kreisl WC. Olfactory Impairment Is Related to Tau Pathology and Neuroinflammation in Alzheimer's Disease. J Alzheimers Dis. 2021;80(3):1051-1065. doi: 10.3233/JAD-201149. PubMed 33646153 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 21, 2022

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03373604
Lead sponsor
Patrick Lao
Collaborators
National Institute on Aging (NIA)
Responsible party
Patrick Lao (Assistant Professor of Neurological Sciences, Columbia University) — Sponsor-investigator
First posted
Dec 14, 2017
Start date
Dec 11, 2017
Primary completion
May 11, 2022
Completion
May 11, 2022
Results posted
May 8, 2025
Last update
May 8, 2025

Study contacts

Patrick Lao, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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