CLINICAL TRIAL

18F-MK-6240 for Alzheimer Disease

Recruiting · 65+ · All Sexes · New York, NY

This study is evaluating whether a laser treatment may help treat memory problems in older adults.

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About the trial for Alzheimer Disease

Eligible Conditions
Alzheimer Disease · Mild Cognitive Impairment (MCI) · Cognitive Dysfunction

Treatment Groups

This trial involves 2 different treatments. 18F-MK-6240 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Active tPBM-2.0
DEVICE
18F-MK-6240
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Sham tPBM-2.0
DEVICE
18F-MK-6240
DRUG

Eligibility

This trial is for patients born any sex aged 65 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
65 years old or older, and 85 years old or younger. show original
This person has amnestic MCI, which is a type of dementia that affects memory show original
A consent form allows study staff to interview a willing relative or spouse to confirm subject reports. show original
To be successful in today's job market, you'll need at least a high school diploma show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Month 3
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Month 3.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether 18F-MK-6240 will improve 10 secondary outcomes in patients with Alzheimer Disease. Measurement will happen over the course of Baseline, up to Week 8.

Change in Systemic Assessment for Treatment Emergent Events - Specific Inquiry (SAFTEE-SI) Score
BASELINE, UP TO WEEK 8
SAFTEE-SI is a list of 55 symptoms. Participants indicate how bothersome each symptom has been for them by circling the appropriate number (0-none, 1-mild, 2-moderate, 3-severe). The total range of score is 0 - 165. The higher the score, the more severely bothersome the symptoms are.
Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) Total Scale Index Score.
BASELINE, MONTH 3
RBANS is s a brief, individually administered battery to measure cognitive decline or improvement. Total Scale Index Score Range = 40-160. A higher score indicates better performance.
Pattern Comparison Test Score
MONTH 3
The total range of score is 0-30. A higher raw score indicates better performance.
Addenbrooke's Cognitive Examination (ACE-III) Score
MONTH 3
ACE-III is a screening test that is composed of tests of attention, orientation, memory, language, visual perceptual and visuospatial skills. The total range of raw score is 0-100. A higher score indicates more intact cognitive functioning.
Face-Name Associative Memory Exam (FNAME-12) Score
MONTH 3
FNAME-12 is an associative memory test where participants see a series of facial photos and names and are asked to remember the face-name pairs.
TMT-B T-Score
MONTH 3
In TMT-B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern (alternating numbers and letters). The time is takes to connect the "trail" is recorded. Range = 0 - 100. A higher T-score indicates better performance
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of alzheimer disease?

Decrease in cognition and memory is often not noticed by the caregivers of the person with AD at the onset of the condition. Decrease in behavior and mood accompanies cognitive impairment and is the main complaint noticed by caregivers. Other signs noticed are difficulty in feeding, urination, and bowel control difficulties. Neuropsychiatric features such as personality changes, and agitation and dementia may be present from the onset of the condition. Behavioral symptoms that occur after the onset of the disease, such as inappropriate speech and aggression, may be misinterpreted as the results of psychotic episodes and may result in a delayed diagnosis.

Anonymous Patient Answer

What causes alzheimer disease?

Alzheimer disease (AD) appears to be related to genetics and age, and a number of known risk factors including sex, environment, and health behaviors may also influence susceptibility. Most current knowledge, however, has centered on mutations in specific genes associated with familial AD and rare, monogenic forms of the disease. However, there also may be rare cases involving mutations in genes that are also known to have a significant impact on risk for normal aging or other diseases. More recently, however, it became apparent that a number of common genetic variants related to Alzheimer disease may actually increase risk for Alzheimer-associated diseases.

Anonymous Patient Answer

How many people get alzheimer disease a year in the United States?

If current rates continue over the next 20 years, more than one million Americans are likely to have Alzheimer's disease. If current trends change, as anticipated by some, the projected number of Americans who have this disease will nearly double.

Anonymous Patient Answer

What is alzheimer disease?

AD is a progressive disease marked by behavioral disorders, cognitive deficits, and a shortage of productive brain functioning. The most common type of AD is Alzheimer's disease. It has a prevalence of about 2% in the USA among people 65 and over. In nursing homes, about half the patients are AD patients with about the same number of female patients receiving AD treatments.

Anonymous Patient Answer

Can alzheimer disease be cured?

Even if our study shows good results in terms of a reduction of the cognitive decline, an effect has to be attributed to the therapy only. Even though we found positive effects on the activities of daily living, an effect on neuropsychiatric symptoms was not observed, which may be explained by methodological reasons.

Anonymous Patient Answer

What are common treatments for alzheimer disease?

Tasks that can improve the quality of life of people with AD are of great importance for them and can be targeted by health care providers when considering the type of treatment to offer.

Anonymous Patient Answer

Who should consider clinical trials for alzheimer disease?

In general, patients' knowledge and perceptions and patient-clinician relationships matter for the ability to motivate patients to enroll in clinical trials. Physicians and other clinicians should take a proactive approach to promoting enrollment of patients with cognitive impairment in clinical trials.

Anonymous Patient Answer

How does 18f-mk-6240 work?

Each individual (n=9) was scanned four times with a total of four time-point scans and was examined pre- and post-incubation for changes in amyloid-β (Aβ) and tau (MAPT). Results indicate that 18F-MK-6240 did not produce reductions in Aβ levels. It was also not able to prevent the progression of tau hyperphosphorylation assessed as the increase in tau S262. Further work on the mechanisms of action and the potential utility of 18F-MK-6240 is ongoing. This paper is open access under the terms of the BioMed Central Open Access Policy.

Anonymous Patient Answer

What is the primary cause of alzheimer disease?

[Alzheimer disease is caused by accumulation of amyloid beta () particles in the brain, primarily in the regions that process memory such as the hippocampus and portions of the cerebral cortex. For a long time, there have been two major theories for the exact origin of the amyloid particle. One theory was that it came from a protein that is normally produced in the nervous system, and the other was that the amyloid beta came from an organism that died elsewhere in the body, with the amyloid being spread via the nerve cells during their life cycles.

Anonymous Patient Answer

What is the latest research for alzheimer disease?

The latest literature shows that the majority of studies in this area are not relevant to our daily clinical practice. Our studies suggest a few ways by which more targeted research may be accomplished for primary or secondary prevention.

Anonymous Patient Answer

Is 18f-mk-6240 typically used in combination with any other treatments?

MK-6240 when given in combination with other drugs exhibited only low-level activity. However, MK-6240 activity could be significantly increased by the combination with AIs, tricyclic antidepressants or anxiolytics in a dose-response dependent manner. Results from a recent paper suggest that MK-6240 alone is not a promising compound for AD treatment or for improving cognitive performance in AD patients. However, further development of combinated MK-6192 is warranted, especially with AIs, tricyclic antidepressants or anxiolytics.

Anonymous Patient Answer
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