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Alzheimer DiseasePhase 2NCT06223360

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

A Phase 2 study testing Low Dose Benfotiamine and High Dose Benfotiamine in people with Alzheimer Disease, run by Weill Medical College of Cornell University at 47 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 to 89 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Low Dose Benfotiamine and High Dose Benfotiamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
406 participants
Where
47 sitesUnited States
Study dates
28 Mar 2024to 1 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 50 to 89 (inclusive) at screening
  • Mild Cognitive Impairment (MCI) due to AD or Mild dementia due to AD according to workgroups of the Diagnostic Guidelines of the National Institute on Aging and Alzheimer's Association (NIA-AA)
  • Mini-Mental State Examination (MMSE) score 20-30 inclusive at screening-. Montreal Cognitive Assessment score (MoCA) < 26 at screening
  • Clinical Dementia Rating (CDR) global score of 0.5 or 1 with memory score of greater or equal to 0.5 at screening
  • Positive plasma AD biomarker signature
  • Participants who are treated with FDA-approved acetylcholinesterase inhibitors (AchEI)and/or memantine will have to be on a stable dosage regimen for at least 3 months prior to screening.
Show all 11Show fewer
  • Participants must have a study partner who has frequent interaction with them (approximately >3-4 times per week), will be available for all clinic visits in person or remotely, and can assist in compliance with study procedures.
  • Female participants must be post-menopausal for at least one year or surgically sterile(bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months prior to screening.
  • Fluent in English or Spanish to ensure compliance with cognitive testing and study visit procedures.
  • Ambulatory, or able to walk with an assistive device.
  • Provision of informed consent from the participant (or the participant's legally authorized representative (LAR) if unable to provide consent) and the study partner.

Who cannot join

  • Significant neurological disorder other than AD (e.g. hypoxia, stroke, traumatic brain injury
  • Significant neurodegenerative diseases, other than AD, and causes of dementias, Parkinson's disease and Huntington's disease, vascular dementia, CJD (Creutzfeldt-Jakob disease), LBD (Lewy Body dementia), PSP (Progressive Supranuclear Palsy), AIDS (Acquired Immunodeficiency Syndrome), or NPH (normal pressure hydrocephalus).
  • Meeting Diagnostic Criteria for Possible AD according to workgroups of the Diagnostic Guidelines of the NIA-AA.
  • A current diagnosis of uncontrolled Type I or Type II diabetes mellitus, as defined by Hemoglobin A1C (Hb A1C ≥ 8).
  • A current active, uncontrolled seizure disorder.
  • Diagnosis of cancer, except for those participants who have undergone potentially curative therapy with no evidence of recurrence for > 5 years.
Show all 12Show fewer
  • History of alcoholism or substance abuse, current or within past 5 years.
  • Previous exposure to Benfotiamine within past 3 months.
  • Contraindication to MRI.
  • Participation in another clinical trial for an investigational agent and having taken at least one dose of study drug, unless confirmed as having been on placebo, within 4 weeks prior to the baseline visit. The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.
  • Initiation of a monoclonal antibody treatment targeting brain amyloid within 6 months prior to the baseline visit.
  • A disability that may prevent the patient from completing all study requirements e.g.,blindness, deafness, severe language difficulty).

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • Albany Medical College

    Albany, New York, 12208

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • University of Michigan, Ann Arbor

    Ann Arbor, Michigan, 48109

  • Emory University Goizueta Alzheimer's Disease Research Center(GADRC)

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Integrative Clinical Trials

    Brooklyn, New York, 11229

  • Ralph H. Johnson VA Health Care System

    Charleston, South Carolina, 29401

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Neuron Clinic

    Chula Vista, California, 91910

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Ohio State University

    Columbus, Ohio, 43221

  • Sandhill Research, LLC d/b/a Accel Research Sites

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of California, Irvine

    Irvine, California, 92697

  • Pacific Research Network

    Lemon Grove, California, 91945

  • University of Kentucky

    Lexington, Kentucky, 40504

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars Sinai, Los Angeles

    Los Angeles, California, 90048

  • AMC Research LLC, dba Flourish Research

    Matthews, North Carolina, 28105

  • CCM Clinical Research Group, LLC

    Miami, Florida, 33133

  • Gonzalez MD & Aswad MD Health Services

    Miami, Florida, 33135

  • Miami Jewish Health

    Miami, Florida, 33137

  • Blue Medical Research Inc.

    Miami, Florida, 33144

  • Brainstorm Research

    Miami, Florida, 33176

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Rutgers, Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Nathan Kline Institute for Psychiatric Research

    New York, New York, 10962

  • St. Joseph's Hospital and Medical Center/Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Oregon Health & Science University (OHSU)

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Perseverance Research Center, LLC

    Scottsdale, Arizona, 85253

  • Southern Illinois University

    Springfield, Illinois, 62702

  • Brain Matters Research (Kane Center)

    Stuart, Florida, 34997

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • KCA Neurology

    Tennessee City, Tennessee, 37067

  • MedVadis Research

    Waltham, Massachusetts, 02451

  • Geisinger Memory and Cognition Center

    Wilkes-Barre, Pennsylvania, 18711

  • Conquest Research

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Seamless Phase 2A-Phase 2B Randomized Double-Blind Placebo- Controlled Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine which may delay or slow the progression of the symptoms of early Alzheimer's disease.

Read the detailed description

This is a randomized, double-blind, placebo-controlled 18-month clinical trial of benfotiamine in early AD. This trial will include a seamless phase 2A-2B design with a randomized total sample of 406 participants. Participants who are randomized but drop out prior to study drug exposure will be replaced.

Phase 2A of the trial will randomize approximately 150 participants total, in a 1:1:1 to treatment with 1200 mg/day benfotiamine, 600 mg/day benfotiamine or placebo. The primary objective of phase 2A is to determine the highest safe and well tolerated dose of benfotiamine (600 mg or 1200 mg), as evaluated by the rate of tolerability events (TEs), for advancement to long-term 72 week exposure. The highest tolerated dose of benfotiamine will be carried forward from phase 2A to phase 2B.

At the start of phase 2B, all participants enrolled in the two phase 2A active dose arms will receive a new supply of benfotiamine at the selected phase 2B dose. All phase 2A participants will be included in the phase 2 intent-to-treat efficacy population, as assigned to active or placebo treatment. The primary objective of phase 2B is to assess efficacy of benfotiamine on global function and cognition over 72 weeks. In phase 2B, a composite cognitive and functional measure as well as PD biomarkers will be used to evaluate efficacy during the extended treatment period. Phase 2B will also evaluate longer-term safety and tolerability of benfotiamine treatment over 72 weeks.

Being tested
Low Dose Benfotiamine, High Dose Benfotiamine, Placebo
Keywords
Mild Cognitive Impairment, Mild Alzheimer's Disease, Early Alzheimer's disease
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Dose BenfotiamineDrug

    300mg benfotiamine capsules (BID, twice a day)

  • High Dose BenfotiamineDrug

    600mg benfotiamine capsules (BID, twice a day)

  • PlaceboDrug

    Placebo capsules to mimic benfotiamine capsules (BID, twice a day)

Study groups in NCT06223360
Study groupRoleWhat they receive
Low Dose BenfotiamineExperimentalParticipants will take 300mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).
Receives: Drug: Low Dose Benfotiamine
High Dose BenfotiamineExperimentalParticipants will take 600mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).
Receives: Drug: High Dose Benfotiamine
PlaceboPlacebo comparatorParticipants will take placebo capsules twice a day (BID; once in the morning and once in the evening). In the placebo group, capsules will be filled with inactive microcrystalline cellulose. The other capsule components, shape and color are identical between benfotiamine and placebo arms.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2A: The rate of tolerability events (TEs).

    The primary safety outcome in phase 2A is the rate of tolerability events (TEs) compared between active arms (benfotiamine) and placebo arms, at each dose. A TE is counted when either a participant discontinues study drug due to intolerability or experiences a moderate or severe adverse event (AE) that is determined to be possibly, probably or definitely related to study drug.

    Measured: Up to 72 weeks

  2. Phase 2B: The primary cognitive endpoint is the within-participant change from baseline to 72 weeks compared between active arms (benfotiamine) and placebo on the Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13).

    ADAS-Cog13 is a structured psychometric scale that evaluates memory (immediate and delayed word recall; immediate word recognition), receptive and expressive language, orientation, ideational praxis (preparing a letter for mailing), constructional praxis (copying figures), and attention (number cancellation). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions also are obtained. ADAS-Cog13 total score has a range of 0-85; with higher scores indicating greater impairment.

    Measured: 72 weeks

  3. Phase 2B: The primary functional endpoint is the within-participant change from baseline to 72 weeks compared between active arm (benfotiamine) and placebo on the Clinical Dementia Rating - Sum of Boxes (CDR-SB).

    CDR-SB is a composite rating of cognition and everyday function which incorporates both informant input and direct assessment of performance. It assesses through semi-structured interview three cognitive domains (memory, orientation, and judgement/problem solving) and three everyday functional domains (community affairs, home and hobbies, personal care). Level of impairment in each of the six domains is rated from none (score=0) to severe (score=3). The six domain scores are then summed to create the CDR-SB. Range 0-18; higher scores indicate greater impairment.

    Measured: 72 weeks

Secondary outcomes (13)

  1. Number of Participants With Adverse Events (AEs) and Serious AEs.

    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes. An AE is considered "Related" for causality designations of possible, probable and definite. The number of AEs and SAEs will be compared between active arms (benfotiamine) and placebo arm.

    Measured: 72 weeks

  2. Number of Participant Withdrawals from the study.

    Number of participant withdrawals from the study for all reasons during the study period (baseline to 72 weeks). Number of participant withdrawals will be compared between active arms (benfotiamine) and placebo arm.

    Measured: 72 weeks

  3. Number of Participant Drug Discontinuations.

    Number of participant drug discontinuations during the study period (baseline to 72 weeks). Number of participant drug discontinuations will be compared between active arms (benfotiamine) and placebo arm.

    Measured: 72 weeks

  4. Mean Thiamine levels (nmol/L).

    Measures of thiamine will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure mean thiamine levels (nmol/L) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  5. Median Thiamine levels (nmol/L).

    Measures of thiamine will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure median thiamine levels (nmol/L) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  6. Mean Thiamine Diphosphate (ThDP) levels (nmol/L).

    Measures of thiamine diphosphate (ThDP) will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure mean Thiamine Diphosphate (ThDP) levels (nmol/L) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  7. Median Thiamine Diphosphate (ThDP) levels (nmol/L).

    Measures of thiamine diphosphate (ThDP) will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure median Thiamine Diphosphate (ThDP) levels (nmol/L) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  8. Mean Thiamine Monophosphate (ThMP) levels (nmol/L).

    Measures of thiamine monophosphate (ThMP) will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure mean Thiamine Monophosphate (ThMP) levels (nmol/L) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  9. Median Thiamine Monophosphate (ThMP) levels (nmol/L).

    Measures of thiamine monophosphate (ThMP) will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure median Thiamine Monophosphate (ThMP) levels (nmol/L) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  10. Mean levels of ThDP Activation of Transketolase (U/g haemoglobin (U/gHb)).

    Measures of ThDP activation of transketolase will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure mean hDP Activation of Transketolase (U/g haemoglobin (U/gHb)) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  11. Median levels of ThDP Activation of Transketolase (U/g haemoglobin (U/gHb)).

    Measures of ThDP activation of transketolase will be provided as blood markers of efficacy of drug delivery. These measurements will be conducted on whole blood and red blood cells. Blood samples to measure median hDP Activation of Transketolase (U/g haemoglobin (U/gHb)) will be collected on all participants and results compared between active arms (benfotiamine) and placebo arm at baseline and week 72.

    Measured: Baseline, week 72

  12. Phase 2B: within-participant change from baseline to 72 weeks compared between active (benfotiamine) arms and placebo arm on The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-ADL-MCI).

    The ADCS-ADL-MCI is a structured questionnaire completed with the informant to assess the participant's ability to perform basic and instrumental activities of daily living. Activities assessed include dressing; social and occupational functioning; household chores and use of tools; interest in and ability to carry out hobbies; shopping and meal preparation; managing appointments; using a phone and computer/tablet.

    Measured: 72 weeks

  13. Phase 2B: within-participant change from baseline to 72 weeks compared between active arms (benfotiamine) and placebo arm on the Montreal Cognitive Assessment (MoCA).

    The MoCA is a brief mental status exam, which assesses numerous cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Range: 0-30; lower scores indicate more cognitive impairment.

    Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start28 Mar 2024
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223360
Sponsor's protocol ID
ADC-061-BENFO
Other IDs
1R01AG076634-01
Status last verified
Sep 2026
First submitted
20 Dec 2023
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data sharing is integral to the ADCS's mission to develop and execute innovative clinical trials focused on interventions that may prevent, delay, or treat the expression of Alzheimer's disease and related dementias. The ADCS is committed to sharing resources and tools, including data, biospecimens, trial designs, outcome and analysis measures following NIH guidelines.

Publications

  • 1. 2017 Alzheimer's disease facts and figures. Alzheimer's Association; The Journal of the Alzheimer's Association, 2017.

  • Pan X, Gong N, Zhao J, Yu Z, Gu F, Chen J, Sun X, Zhao L, Yu M, Xu Z, Dong W, Qin Y, Fei G, Zhong C, Xu TL. Powerful beneficial effects of benfotiamine on cognitive impairment and beta-amyloid deposition in amyloid precursor protein/presenilin-1 transgenic mice. Brain. 2010 May;133(Pt 5):1342-51. doi: 10.1093/brain/awq069. Epub 2010 Apr 12.

    PubMed 20385653

  • Tapias V, Jainuddin S, Ahuja M, Stack C, Elipenahli C, Vignisse J, Gerges M, Starkova N, Xu H, Starkov AA, Bettendorff L, Hushpulian DM, Smirnova NA, Gazaryan IG, Kaidery NA, Wakade S, Calingasan NY, Thomas B, Gibson GE, Dumont M, Beal MF. Benfotiamine treatment activates the Nrf2/ARE pathway and is neuroprotective in a transgenic mouse model of tauopathy. Hum Mol Genet. 2018 Aug 15;27(16):2874-2892. doi: 10.1093/hmg/ddy201.

    PubMed 29860433

  • Anandam KY, Srinivasan P, Yasujima T, Al-Juburi S, Said HM. Proinflammatory cytokines inhibit thiamin uptake by human and mouse pancreatic acinar cells: involvement of transcriptional mechanism(s). Am J Physiol Gastrointest Liver Physiol. 2021 Jan 1;320(1):G108-G116. doi: 10.1152/ajpgi.00361.2020. Epub 2020 Nov 4.

    PubMed 33146542

  • He Y, Zhou C, Huang M, Tang C, Liu X, Yue Y, Diao Q, Zheng Z, Liu D. Glyoxalase system: A systematic review of its biological activity, related-diseases, screening methods and small molecule regulators. Biomed Pharmacother. 2020 Nov;131:110663. doi: 10.1016/j.biopha.2020.110663. Epub 2020 Aug 25.

    PubMed 32858501

  • 6. Yang, Y., et al., Succinylation Links Metabolic Reductions to Amyloid and Tau Pathology. 2019, bioRxiv.

  • Gibson GE, Luchsinger JA, Cirio R, Chen H, Franchino-Elder J, Hirsch JA, Bettendorff L, Chen Z, Flowers SA, Gerber LM, Grandville T, Schupf N, Xu H, Stern Y, Habeck C, Jordan B, Fonzetti P. Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial. J Alzheimers Dis. 2020;78(3):989-1010. doi: 10.3233/JAD-200896.

    PubMed 33074237

  • Alzheimer's Association National Plan Milestone Workgroup; Fargo KN, Aisen P, Albert M, Au R, Corrada MM, DeKosky S, Drachman D, Fillit H, Gitlin L, Haas M, Herrup K, Kawas C, Khachaturian AS, Khachaturian ZS, Klunk W, Knopman D, Kukull WA, Lamb B, Logsdon RG, Maruff P, Mesulam M, Mobley W, Mohs R, Morgan D, Nixon RA, Paul S, Petersen R, Plassman B, Potter W, Reiman E, Reisberg B, Sano M, Schindler R, Schneider LS, Snyder PJ, Sperling RA, Yaffe K, Bain LJ, Thies WH, Carrillo MC. 2014 Report on the Milestones for the US National Plan to Address Alzheimer's Disease. Alzheimers Dement. 2014 Oct;10(5 Suppl):S430-52. doi: 10.1016/j.jalz.2014.08.103.

    PubMed 25341459

  • Greenwood J, Love ER, Pratt OE. Kinetics of thiamine transport across the blood-brain barrier in the rat. J Physiol. 1982 Jun;327:95-103. doi: 10.1113/jphysiol.1982.sp014222.

    PubMed 7120152

  • Reggiani C, Patrini C, Rindi G. Nervous tissue thiamine metabolism in vivo. I. Transport of thiamine and thiamine monophosphate from plasma to different brain regions of the rat. Brain Res. 1984 Feb 20;293(2):319-27. doi: 10.1016/0006-8993(84)91239-3.

    PubMed 6697223

  • Gibson GE, Sheu KF, Blass JP, Baker A, Carlson KC, Harding B, Perrino P. Reduced activities of thiamine-dependent enzymes in the brains and peripheral tissues of patients with Alzheimer's disease. Arch Neurol. 1988 Aug;45(8):836-40. doi: 10.1001/archneur.1988.00520320022009.

    PubMed 3395256

  • Gold M, Hauser RA, Chen MF. Plasma thiamine deficiency associated with Alzheimer's disease but not Parkinson's disease. Metab Brain Dis. 1998 Mar;13(1):43-53. doi: 10.1023/a:1020678912330.

    PubMed 9570639

  • Bubber P, Haroutunian V, Fisch G, Blass JP, Gibson GE. Mitochondrial abnormalities in Alzheimer brain: mechanistic implications. Ann Neurol. 2005 May;57(5):695-703. doi: 10.1002/ana.20474.

    PubMed 15852400

  • Gibson GE, Haroutunian V, Zhang H, Park LC, Shi Q, Lesser M, Mohs RC, Sheu RK, Blass JP. Mitochondrial damage in Alzheimer's disease varies with apolipoprotein E genotype. Ann Neurol. 2000 Sep;48(3):297-303.

    PubMed 10976635

  • Butterworth RF, Besnard AM. Thiamine-dependent enzyme changes in temporal cortex of patients with Alzheimer's disease. Metab Brain Dis. 1990 Dec;5(4):179-84. doi: 10.1007/BF00997071.

    PubMed 2087217

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose Benfotiamine and High Dose Benfotiamine in people with Alzheimer Disease, run by Weill Medical College of Cornell University at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2A: The rate of tolerability events (TEs). (time frame: Up to 72 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06223360, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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