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
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.
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 71 is close to the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Patrick Lao is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alzheimer's disease (mild cognitive impairment or mild stage Alzheimer's disease dementia)
Drug: 18F-MK-6240 · Procedure: Lumbar Puncture (optional)
Healthy controls
Drug: 18F-MK-6240 · Procedure: Lumbar Puncture (optional)
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
Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
18F-MK-6240 Binding
Standardized uptake value ratio (SUVr)
Time frame: 1 day
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
| Milestone | No Cognitive Impairment | Cognitive Impairment |
|---|---|---|
| Started | 43 | 28 |
| Completed | 43 | 28 |
| Not completed | 0 | 0 |
Standardized uptake value ratio (SUVr)
| SUVr | No Cognitive Impairment | Cognitive Impairment |
|---|---|---|
| 18F-MK-6240 Binding | 1.41 ± 0.43 | 2.30 ± 0.92 |
Correlation of 18F-MK-6240 binding and CSF markers of neurodegeneration and inflammation.
| correlation coefficient (r) | No Cognitive Impairment | Cognitive Impairment |
|---|---|---|
| Correlation between Tau and Neurodegeneration | -0.347 | 0.013 |
| Correlation between Tau and Inflammation | -0.295 | 0.181 |
Collected over During the scanning procedure (1 day), and at 1 year follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Cognitive Impairment | 0/43 (0%) | 0/43 (0%) | 4/43 (9.3%) |
| Cognitive Impairment | 0/28 (0%) | 0/28 (0%) | 4/28 (14.3%) |
| Event | No Cognitive Impairment | Cognitive Impairment |
|---|---|---|
| Sore arm from IV placementInjury, poisoning and procedural complications | 0/43 | 1/28 |
| Elevated blood pressureBlood and lymphatic system disorders | 1/43 | 1/28 |
| musculoskeletal painMusculoskeletal and connective tissue disorders | 0/43 | 1/28 |
| FallInjury, poisoning and procedural complications | 0/43 | 1/28 |
| hypoglycemiaBlood and lymphatic system disorders | 1/43 | 0/28 |
| Chest painGeneral disorders | 1/43 | 0/28 |
| lightheadednessGeneral disorders | 1/43 | 0/28 |
| Age, Continuous(years) | No Cognitive Impairment | Cognitive Impairment | Total |
|---|---|---|---|
| Mean | 70.6 ± 8.6 | 69.5 ± 10.2 | 70.1 ± 9.2 |
| Sex: Female, Male(Participants) | No Cognitive Impairment | Cognitive Impairment | Total |
|---|---|---|---|
| Female | 21 | 7 | 28 |
| Male | 22 | 21 | 43 |
| Ethnicity (NIH/OMB)(Participants) | No Cognitive Impairment | Cognitive Impairment | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 40 | 26 | 66 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | No Cognitive Impairment | Cognitive Impairment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 2 | 18 |
| White | 27 | 26 | 53 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | No Cognitive Impairment | Cognitive Impairment | Total |
|---|---|---|---|
| United States | 43 | 28 | 71 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in May 2022, 53 months.
Results were first posted in May 2025, 2 years 11 months after primary completion.
Of 127 non-industry phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 69. This study's 53 months is close to that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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