Biomarker Database for Alzheimer's Disease

(Bio-Hermes-002 Trial)

Recruiting at 21 trial locations

Overseen By Jenn Gaudioso, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GAP Innovations, PBC

Must not be taking: Disease modifying AD treatments

Disqualifiers: Stroke, Seizures, Cancer, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if digital and blood-based markers can predict brain changes related to Alzheimer's disease, such as tau and amyloid buildup, using PET scans (a type of brain imaging). Researchers intend to create a database of these biomarkers to enhance understanding of Alzheimer's. The trial seeks individuals over 60 years old who are cognitively normal, have mild memory issues, or exhibit mild-to-moderate Alzheimer's symptoms. Participants should either have no significant memory loss or have been diagnosed with mild cognitive impairment or mild-to-moderate Alzheimer's, as verified through medical records.

As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could lead to better understanding and treatment of Alzheimer's disease.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have received any potential disease-modifying Alzheimer's treatment within 6 months before the pre-screening visit.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MK6240 is generally safe for use in clinical studies. In previous research, MK6240, which aids in brain imaging, was well-tolerated by participants. When injected, MK6240 raised no major safety concerns. Some participants experienced minor issues, such as bruising, but no serious side effects were linked to the treatment. Overall, the treatment caused no harmful effects in those who received it, suggesting that MK6240 is safe for further studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the potential of digital and blood-based biomarkers in diagnosing and understanding Alzheimer's disease (AD) and cognitive impairments. Unlike current diagnostic methods that rely heavily on PET imaging, this study explores less invasive and potentially more accessible ways to detect tau and amyloid proteins associated with these conditions. By developing a database of these biomarkers, the trial could pave the way for earlier and more accurate detection, enabling timely intervention and better management of AD and related cognitive disorders.

What evidence suggests that this trial's treatment, MK6240, could be effective for cognitive conditions?

Research has shown that MK6240 effectively detects the build-up of tau protein in the brain, a key indicator of Alzheimer's disease. Studies have found that this tracer, used in PET scans, accurately identifies tau build-up with minimal interference from other brain areas. This understanding links tau spread to memory and thinking problems. Additionally, MK6240 serves as a promising tool for tracking brain changes related to tau, aiding in diagnosing and studying Alzheimer's. These findings suggest that MK6240 can be a valuable marker for identifying and monitoring brain changes associated with Alzheimer's. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have given or my representative has given written consent for me to participate.

I meet the main requirements to participate in the study.

I agree to follow the study's procedures, including giving blood samples and allowing my genetic information and samples to be stored for future research.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants undergo blood, CSF, retinal, digital, MRI, and PET brain imaging to collect biomarker data

120 days

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK6240

How Is the Trial Designed?

Group I: Mild-to-Moderate AD Dementia Experimental Treatment 2 Interventions

A diagnosis of Mild-to-Moderate AD Dementia based on the National Institute of Aging (NIA) criteria and verified through medical records.

Group II: Mild Cognitive Impairment Experimental Treatment 2 Interventions

A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records.

Group III: Cognitively Normal Experimental Treatment 2 Interventions

No reported memory loss or concerns as reported by participant and study partner.

Who Is Running the Clinical Trial?

GAP Innovations, PBC

Lead Sponsor

Trials

2

Recruited

2,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9902412/

Dosimetry and efficacy of a tau PET tracer [18F]MK-6240 in ... This study investigated the safety, radiation dosimetry, pharmacokinetics and biodistribution of [ 18 F]MK-6240 in Japanese elderly subjects.

2. jnm.snmjournals.org jnm.snmjournals.org/content/60/1/93

In Vivo Characterization and Quantification of Neurofibrillary ... 18 F-MK-6240 is a promising PET radioligand for in vivo imaging of neurofibrillary tau aggregates in AD with minimal off-target binding in the human brain.

3. investors.biogen.com investors.biogen.com/news-releases/news-release-details/new-clinical-data-demonstrates-three-years-continuous-treatment

New Clinical Data Demonstrates Three Years ... 51% of No Tau / Low Tau Patients Showed Improved Cognition and Function Over Three Years; Only Lecanemab Has Clinical Data in No Tau / Low ...

4. link.springer.com link.springer.com/article/10.1007/s00259-024-06603-2

The spatial extent of tauopathy on [ 18 F]MK-6240 tau PET ... Our study aimed to evaluate whether cognitive impairment would be more closely associated with the spatial extent than with the intensity of tau-PET signal.

5. academic.oup.com academic.oup.com/brain/article/145/5/1763/6402002

18F-MK-6240 tau-PET in genetic frontotemporal dementia However, a recent study proposed that MK-6240 may be an effective biomarker in preclinical Alzheimer's disease,54 and our findings suggest that the tracer may ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31111397/

Preclinical Safety Evaluation and Human Dosimetry of [ 18 ... Microdoses of [ 18 F]MK-6240 are safe for clinical positron emission tomography imaging studies. Single IV administration of 185 MBq (5 mCi) [ 18 F]MK-6240 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03071224

Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging ... To acquire safety data following injection of [18F]MK-6240. To determine the longitudinal change in tau burden (including SUVR and tau distribution metrics) ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/60/1/107

Brain Imaging of Alzheimer Dementia Patients and Elderly ... The 18F-MK-6240 injections were well tolerated, with no pharmacologic effects. Five subjects reported adverse events characterized as bruising ...

9. trialstransparency.msdclinicaltrials.com trialstransparency.msdclinicaltrials.com/Upload/428_synopsis_final-redaction.pdf

2 SYNOPSIS SPONSOR - MSD Clinical Trials To investigate the safety and tolerability of single IV doses (up to 2 injections) of [18F]MK-6240 in patients with AD amnestic. MCI, and in cognitively normal ...