← Back to Search

Sirtuin-NAD Activator

Sirtuin-NAD Activator for Alzheimer's Disease

Phase 1 & 2
Recruiting
Led By Shalender Bhasin, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A man or a woman between the ages of 55 and 85 years (inclusive)
Meets National Institute on Aging-Alzheimer's Association (NIA-AA) clinical diagnostic criteria for AD dementia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90
Awards & highlights

Study Summary

This trial is testing whether a drug called MIB-626 can help treat Alzheimer's disease by improving brain function and reducing biomarkers of aging.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified here but may include typical drug reactions such as gastrointestinal issues, headaches, dizziness, or allergic reactions based on its impact on brain chemistry.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 55 and 85 years old.
Select...
I have been diagnosed with Alzheimer's disease according to NIA-AA guidelines.
Select...
My memory test score is lower than expected for my education level.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in CSF concentrations of MIB-626
Secondary outcome measures
change in CSF concentrations of MIB-626 metabolites, nicotinamide (NAM), NR, 2-PY, and MeNAM
change in NAD concentrations in peripheral blood mononuclear cells
Brain
+1 more
Other outcome measures
Change in circulating biomarkers of amyloid deposition (Aβ-42, Aβ-40), neuronal/axonal degeneration (t-tau, p-tau, NFL), synaptic function (neurogranin), and neuroinflammation (YKL40, GFAP)
Change in cognition
Change in instrumental activities of daily living (IADL)
+2 more

Side effects data

From 2022 Phase 2 trial • 7 Patients • NCT04817111
14%
Constipation
14%
Belching
14%
Back pain
14%
Neck pain
14%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label - MIB-626

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MIB-626Experimental Treatment1 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 TabletPlacebo Group1 Intervention
Subjects will be randomized to receive either the placebo or MIB-626 tablets twice a day orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MIB-626
2021
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,614 Previous Clinical Trials
11,470,785 Total Patients Enrolled
Shalender Bhasin, MDPrincipal InvestigatorBrigham and Women's Hospital
15 Previous Clinical Trials
7,467 Total Patients Enrolled
Neha K Rupeja, MSStudy DirectorBrigham and Women's Hospital

Media Library

MIB-626 (Sirtuin-NAD Activator) Clinical Trial Eligibility Overview. Trial Name: NCT05040321 — Phase 1 & 2
Alzheimer's Disease Research Study Groups: MIB-626, Placebo Tablet
Alzheimer's Disease Clinical Trial 2023: MIB-626 Highlights & Side Effects. Trial Name: NCT05040321 — Phase 1 & 2
MIB-626 (Sirtuin-NAD Activator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05040321 — Phase 1 & 2
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT05040321 — Phase 1 & 2

Frequently Asked Questions

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

Is this research endeavor currently recruiting participants?

"Per information present on clinicaltrials.gov, this medical trial is still open for enrolment. The first posting was made December 1st 2021 and the last updates were applied July 11th 2022."

Answered by AI

How many participants have thus far signed up for this experimental research?

"Affirmative. The information on clinicialtrials.gov confirms that this trial is presently enrolling participants, which it began doing since December 1st 2021 and was last modified July 11th 2022. This medical study requires 50 individuals from a single centre to take part in the research."

Answered by AI

What are the qualifications for participation in this research study?

"This clinical trial seeks to recruit 50 individuals, aged between 55 and 85, who have already been diagnosed with dementia. All potential participants must also possess a Mini-Mental State Exam score of 18-26 (inclusive), under 6 on the Geriatric Depression Scale 15 item version, an impaired memory performance below education adjusted cut off scores for Logical Memory II subscale delayed paragraph recall; adequate visual/auditory acuity; a Clinical Dementia Rating global score of 0.5 or 1; and be able to provide access to an informant (study partner) with regular contact that knows them well."

Answered by AI

Would adults aged 25 and above be eligible for this trial?

"Patients aged 55 to 85 are eligible for enrolment in this research. Additionally, there are 34 studies available for those younger than 18 and 750 trials suitable for people older than 65 years old."

Answered by AI

What is the primary purpose of this investigation?

"This 90-day trial is assessing the modification of βNMN concentrations in cerebrospinal fluid (CSF). Additional objectives focus on registering deviations from baseline to day 90 for NMN's metabolites, NAD levels in peripheral blood mononuclear cells using LC-MS/MS test protocols and biomarkers associated with aging including HbA1C, IGF1, T3, IL6, TNF-alpha and urinary F2-isoprostane."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Massachusetts
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Brigham and Women's Hospital

What questions have other patients asked about this trial?

How are the screening interviews done?
PatientReceived no prior treatments

Why did patients apply to this trial?

I’ve entered this information on behalf of my mother who has had fairly recent diagnosis of dementia.
PatientReceived no prior treatments
~0 spots leftby Apr 2024