Can a 'Longevity' molecule reach the brain and fight Alzheimer's?
NCT ID NCT05040321
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This early-phase trial tests whether MIB-626, a drug that activates sirtuin-NAD pathways, can reach the brain and affect aging-related markers in people with mild Alzheimer's. 22 participants will take either MIB-626 or a placebo for 90 days. The study primarily checks if the drug enters the cerebrospinal fluid and engages its target, not whether it improves memory or daily function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MIB-626 (a sirtuin-NAD activator)
- What this could lead to
- If successful, this could point toward a treatment that targets multiple Alzheimer's-related processes, like brain energy and inflammation.
- What could go wrong
- This is a very small, early-phase trial with only 22 people, focused on safety and brain penetration—not on whether the drug improves symptoms or slows the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
22 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
-
Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
55 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. A man or a woman between the ages of 55 and 85 years (inclusive) 2. Meets National Institute on Aging-Alzheimer's Association (NIA-AA) clinical diagnostic criteria for AD dementia 3. Has evidence of AD pathological process by a positive amyloid assessment with cerebrospinal fluid (CSF) Aβ42 4. Has a Clinical Dementia Rating (CDR) global score of 0.5 or 1 5. Has a Mini-Mental State Exam (MMSE) Score of 18 to 26 (inclusive) 6. Has a 15-item Geriatric Depression Scale (GDS) score of \< 6 7. Impaired memory performance below education adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall (LM-IIa) of the Wechsler Memory Scale-Revised (WMS-R) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2) 8. May take Food and Drug Administration (FDA) approved medications for the treatment of AD dementia (cholinesterase inhibitors and/or memantine), but if taking such medications, they must be stable for at least 8 weeks before screening 9. Has adequate visual and auditory acuity to participate in neuropsychological testing and other study assessments 10. Has the availability of an informant (study partner) who has regular contact with the participant and knows him/her well 11. Is willing and able to participate in all assessments in English 12. Is capable of providing written informed consent Exclusion Criteria: Subjects may not be enrolled if: 1. Neurologic diseases: Any significant neurologic disease other than AD that can lead to cognitive impairment, such as Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, corticobasal syndrome, brain tumor, seizure disorder, subdural hematoma (within the last 1 year), multiple sclerosis, or history of significant head trauma (e.g. loss of consciousness for 30 minutes or more) followed by persistent neurologic deficits or known structural brain abnormalities. 2. 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. 3. History of alcohol or substance use disorder or dependence (DSM V criteria) within the last 2 years. 4. Psychiatric disorder: Major depressive disorder (within the last 1 year), bipolar disorder, schizophrenia (DSM V criteria), or current major psychotic symptoms or behavioral problems that could interfere with study procedures. 5. Any significant systemic illness or unstable medical condition, which could obfuscate cognitive aging or neurodegenerative trajectories or affect valid cognitive and self-report measurements. 6. Excluded medications: Niacin or dietary supplements containing nicotinamide mononucleotide (NMN) or nicotinamide riboside (NR); antipsychotic medications, antidepressant medications with anticholinergic side effects. Washout from psychoactive medications for at least 8 weeks before screening. 7. Current use of anticoagulants; significant back or spine disease that would make a lumbar puncture difficult or unsafe as determined by a clinician. 8. Other laboratory abnormalities: Has AST or ALT \> 3 times the upper limit of normal; serum creatinine \> 2.0 mg/d; HbA1C \> 8.5% 9. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter 10. Other medical conditions which, in the opinion of the investigator, would jeopardize safety or impact the validity of the study results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115-0000, United States
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