Sirtuin-NAD Activator for Alzheimer's Disease

Overseen by Shalender Bhasin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Brigham and Women's Hospital

Trial Summary

What is the purpose of this trial?

This trial tests if MIB-626, a pill that boosts NAD levels, can cross into the brain and help people with mild Alzheimer's disease. The goal is to see if it improves brain health and reduces aging markers. NADH has been previously tested in Alzheimer's disease with mixed results, showing some cognitive improvements in some studies but not in others.

Research Team

Shalender Bhasin, MD

Principal Investigator

Brigham and Women's Hospital

Neha K Rupeja, MS

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults aged 55-85 with Alzheimer's Disease, scoring low on memory and mental state exams, not suffering from other cognitive impairments or unstable medical conditions. Participants must have a reliable informant and be able to consent and participate in English.

Inclusion Criteria

I am between 55 and 85 years old.

I have been diagnosed with Alzheimer's disease according to NIA-AA guidelines.

I have been on stable Alzheimer's medication for at least 8 weeks.

Exclusion Criteria

I do not have any major illnesses that could affect my thinking or memory tests.

I am currently using blood thinners and have back issues that may make a spinal tap risky.

Neuroimaging: Baseline or prior magnetic resonance imaging (MRI) scans with evidence of cortical stroke or hemorrhage, strategically located lacunar stroke (ex: left thalamus), or severe small vessel ischemic disease

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MIB-626 or placebo tablets twice daily for 90 days to evaluate penetration of the blood-brain barrier and engagement of the sirtuin-NAD pathway.

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in neuropsychiatric symptoms, cognition, and biomarkers.

4 weeks

Treatment Details

Interventions

• MIB-626 (Sirtuin-NAD Activator)
• Nicotinamide Mononucleotide (Other)
• Placebo (Other)

Trial Overview The study tests MIB-626, a daily oral drug thought to penetrate the brain barrier and activate the sirtuin-NAD pathway related to aging. Its effects are compared against a placebo by measuring substances in cerebrospinal fluid and blood.

Participant Groups

Group I: MIB-626 Experimental Treatment 1 Intervention

Subjects will either take MIB-626 or placebo tablet twice a day for 90 days. For those who receive MIB-626, we plan on giving subjects 1000mg of the drug, twice a day for 90 days. MIB-626 will be in two 500mg tablets.

Group II: Placebo Tablet Placebo Group 1 Intervention

Subjects will be randomized to receive either the placebo or MIB-626 tablets twice a day orally.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons