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

NCT06223360 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ADC-061-BENFO1R01AG076634-01
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 47

Brief 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.

Conditions

Alzheimer Disease

Keywords

Mild Cognitive Impairment; Mild Alzheimer's Disease; Early Alzheimer's disease

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 72 weeks

• 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.

  72 weeks

• 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.

  72 weeks

Secondary Outcomes (9)

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

  72 weeks

• Number of Participant Withdrawals from the study.

  72 weeks

• Number of Participant Drug Discontinuations.

  72 weeks

• Mean and Median Thiamine levels (nmol/L).

  Baseline, week 72

• Mean and Median Thiamine Diphosphate (ThDP) levels (nmol/L).

  Baseline, week 72

Study Arms (3)

Low Dose Benfotiamine

EXPERIMENTAL

Participants will take 300mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).

Drug: Low Dose Benfotiamine

High Dose Benfotiamine

EXPERIMENTAL

Participants will take 600mg benfotiamine capsules twice a day (BID; once in the morning and once in the evening).

Drug: High Dose Benfotiamine

Placebo

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo

Interventions

Low Dose Benfotiamine DRUG

300mg benfotiamine capsules (BID, twice a day)

Low Dose Benfotiamine

High Dose Benfotiamine DRUG

600mg benfotiamine capsules (BID, twice a day)

High Dose Benfotiamine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Alzheimer's Disease Cooperative Study (ADCS): lead
• Burke Medical Research Institute: collaborator

Study Sites (47)

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

Phoenix, Arizona, 85013, United States

RECRUITING

Perseverance Research Center, LLC

Scottsdale, Arizona, 85253, United States

RECRUITING

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

RECRUITING

The Neuron Clinic

Chula Vista, California, 91910, United States

RECRUITING

University of California, Irvine

Irvine, California, 92697, United States

RECRUITING

Pacific Research Network

Lemon Grove, California, 91945, United States

TERMINATED

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Cedars Sinai, Los Angeles

Los Angeles, California, 90048, United States

RECRUITING

Syrentis Clinical Research

Santa Ana, California, 92705, United States

RECRUITING

JEM Research Institute

Atlantis, Florida, 33462, United States

RECRUITING

Brain Matters Research

Delray Beach, Florida, 33445, United States

RECRUITING

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

RECRUITING

CCM Clinical Research Group, LLC

Miami, Florida, 33133, United States

RECRUITING

Gonzalez MD & Aswad MD Health Services

Miami, Florida, 33135, United States

RECRUITING

Miami Jewish Health

Miami, Florida, 33137, United States

RECRUITING

Blue Medical Research Inc.

Miami, Florida, 33144, United States

RECRUITING

Brainstorm Research

Miami, Florida, 33176, United States

RECRUITING

Brain Matters Research (Kane Center)

Stuart, Florida, 34997, United States

RECRUITING

Conquest Research

Winter Park, Florida, 32789, United States

RECRUITING

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

Atlanta, Georgia, 30329, United States

RECRUITING

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

Decatur, Georgia, 30030, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Southern Illinois University

Springfield, Illinois, 62702, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, 40504, United States

RECRUITING

MedVadis Research

Waltham, Massachusetts, 02451, United States

RECRUITING

University of Michigan, Ann Arbor

Ann Arbor, Michigan, 48109, United States

RECRUITING

Rutgers, Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

Albany Medical College

Albany, New York, 12208, United States

RECRUITING

Dent Neurologic Institute

Amherst, New York, 14226, United States

RECRUITING

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

RECRUITING

Weill Cornell Medical College

New York, New York, 10021, United States

RECRUITING

Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Nathan Kline Institute for Psychiatric Research

New York, New York, 10962, United States

RECRUITING

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

AMC Research LLC, dba Flourish Research

Matthews, North Carolina, 28105, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43221, United States

RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

RECRUITING

Geisinger Memory and Cognition Center

Wilkes-Barre, Pennsylvania, 18711, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, 29401, United States

RECRUITING

KCA Neurology

Tennessee City, Tennessee, 37067, United States

RECRUITING

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

RECRUITING

Froedtert and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Related Publications (31)

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

  BACKGROUND

• 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.

  PMID: 20385653 BACKGROUND

• 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.

  PMID: 29860433 BACKGROUND

• 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.

  PMID: 33146542 BACKGROUND

• 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.

  PMID: 32858501 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 33074237 BACKGROUND

• 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.

  PMID: 25341459 BACKGROUND

• 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.

  PMID: 7120152 BACKGROUND

• 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.

  PMID: 6697223 BACKGROUND

• 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.

  PMID: 3395256 BACKGROUND

• 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.

  PMID: 9570639 BACKGROUND

• 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.

  PMID: 15852400 BACKGROUND

• 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.

  PMID: 10976635 BACKGROUND

• 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.

  PMID: 2087217 BACKGROUND

• Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.

  PMID: 8232972 BACKGROUND

• Mastrogiacomo F, Bergeron C, Kish SJ. Brain alpha-ketoglutarate dehydrogenase complex activity in Alzheimer's disease. J Neurochem. 1993 Dec;61(6):2007-14. doi: 10.1111/j.1471-4159.1993.tb07436.x.

  PMID: 8245957 BACKGROUND

• Gejl M, Brock B, Egefjord L, Vang K, Rungby J, Gjedde A. Blood-Brain Glucose Transfer in Alzheimer's disease: Effect of GLP-1 Analog Treatment. Sci Rep. 2017 Dec 13;7(1):17490. doi: 10.1038/s41598-017-17718-y.

  PMID: 29235507 BACKGROUND

• Gejl M, Gjedde A, Egefjord L, Moller A, Hansen SB, Vang K, Rodell A, Braendgaard H, Gottrup H, Schacht A, Moller N, Brock B, Rungby J. In Alzheimer's Disease, 6-Month Treatment with GLP-1 Analog Prevents Decline of Brain Glucose Metabolism: Randomized, Placebo-Controlled, Double-Blind Clinical Trial. Front Aging Neurosci. 2016 May 24;8:108. doi: 10.3389/fnagi.2016.00108. eCollection 2016.

  PMID: 27252647 BACKGROUND

• Xie F, Cheng Z, Li S, Liu X, Guo X, Yu P, Gu Z. Pharmacokinetic study of benfotiamine and the bioavailability assessment compared to thiamine hydrochloride. J Clin Pharmacol. 2014 Jun;54(6):688-95. doi: 10.1002/jcph.261. Epub 2014 Jan 22.

  PMID: 24399744 BACKGROUND

• Hilbig R, Rahmann H. Comparative autoradiographic investigations on the tissue distribution of benfotiamine versus thiamine in mice. Arzneimittelforschung. 1998 May;48(5):461-8.

  PMID: 9638312 BACKGROUND

• Sheng L, Cao W, Lin P, Chen W, Xu H, Zhong C, Yuan F, Chen H, Li H, Liu C, Yang M, Li X. Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Benfotiamine in Healthy Subjects. Drug Des Devel Ther. 2021 Mar 9;15:1101-1110. doi: 10.2147/DDDT.S296197. eCollection 2021.

  PMID: 33727798 BACKGROUND

• Blass JP, Gibson GE. Abnormality of a thiamine-requiring enzyme in patients with Wernicke-Korsakoff syndrome. N Engl J Med. 1977 Dec 22;297(25):1367-70. doi: 10.1056/NEJM197712222972503.

  PMID: 927453 BACKGROUND

• Gallant J, Chan K, Green TJ, Wieringa FT, Leemaqz S, Ngik R, Measelle JR, Baldwin DA, Borath M, Sophonneary P, Yelland LN, Hampel D, Shahab-Ferdows S, Allen LH, Jones KS, Koulman A, Parkington DA, Meadows SR, Kroeun H, Whitfield KC. Low-dose thiamine supplementation of lactating Cambodian mothers improves human milk thiamine concentrations: a randomized controlled trial. Am J Clin Nutr. 2021 Jul 1;114(1):90-100. doi: 10.1093/ajcn/nqab052.

  PMID: 33829271 BACKGROUND

• Jones KS, Parkington DA, Cox LJ, Koulman A. Erythrocyte transketolase activity coefficient (ETKAC) assay protocol for the assessment of thiamine status. Ann N Y Acad Sci. 2021 Aug;1498(1):77-84. doi: 10.1111/nyas.14547. Epub 2020 Dec 22.

  PMID: 33354793 BACKGROUND

• Whitfield KC, Bourassa MW, Adamolekun B, Bergeron G, Bettendorff L, Brown KH, Cox L, Fattal-Valevski A, Fischer PR, Frank EL, Hiffler L, Hlaing LM, Jefferds ME, Kapner H, Kounnavong S, Mousavi MPS, Roth DE, Tsaloglou MN, Wieringa F, Combs GF Jr. Thiamine deficiency disorders: diagnosis, prevalence, and a roadmap for global control programs. Ann N Y Acad Sci. 2018 Oct;1430(1):3-43. doi: 10.1111/nyas.13919. Epub 2018 Aug 27.

  PMID: 30151974 BACKGROUND

• Gomes F, Bergeron G, Bourassa MW, Fischer PR. Thiamine deficiency unrelated to alcohol consumption in high-income countries: a literature review. Ann N Y Acad Sci. 2021 Aug;1498(1):46-56. doi: 10.1111/nyas.14569. Epub 2021 Feb 11.

  PMID: 33576090 BACKGROUND

• Hammes HP, Du X, Edelstein D, Taguchi T, Matsumura T, Ju Q, Lin J, Bierhaus A, Nawroth P, Hannak D, Neumaier M, Bergfeld R, Giardino I, Brownlee M. Benfotiamine blocks three major pathways of hyperglycemic damage and prevents experimental diabetic retinopathy. Nat Med. 2003 Mar;9(3):294-9. doi: 10.1038/nm834. Epub 2003 Feb 18.

  PMID: 12592403 BACKGROUND

• Stracke H, Hammes HP, Werkmann D, Mavrakis K, Bitsch I, Netzel M, Geyer J, Kopcke W, Sauerland C, Bretzel RG, Federlin KF. Efficacy of benfotiamine versus thiamine on function and glycation products of peripheral nerves in diabetic rats. Exp Clin Endocrinol Diabetes. 2001;109(6):330-6. doi: 10.1055/s-2001-17399.

  PMID: 11571671 BACKGROUND

• 30. Acosta, D.M., D. Eliezer, and G.E. Gibson, Post Translational Modifications by Succinylation and Acetylation, in Reference Module in Life Sciences. 2020, Elsevier.

  BACKGROUND

• Feldman HH, Luchsinger JA, Leger GC, Taylor C, Jacobs DM, Salmon DP, Edland SD, Messer K, Revta C, Flowers SA, Jones KS, Koulman A, Yarasheski KE, Verghese PB, Venkatesh V, Zetterberg H, Durant J, Lupo JL, Gibson GE; ADCS BenfoTeam Study Group. Protocol for 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). PLoS One. 2024 May 29;19(5):e0302998. doi: 10.1371/journal.pone.0302998. eCollection 2024.

  PMID: 38809849 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

benphothiamine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Howard Feldman, MDCM

  Alzheimer's Disease Cooperative Study (ADCS)

  PRINCIPAL INVESTIGATOR

• Gary E. Gibson, PhD

  Burke Neurological Institute

  STUDY DIRECTOR

• Jose A. Luchsinger, MD MPH

  Columbia University

  STUDY DIRECTOR

Central Study Contacts

ADCS Recruitment Team

CONTACT

877-807-1290; adcs-recruitment@health.ucsd.edu

Bryce Truver, MS

CONTACT

619-818-3769; btruver@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 25, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication.
• Access Criteria: Data requestors must complete an ADCS data and sample sharing request form. Upon approval, requestors must complete a data use agreement prior to accessing the data.

Locations

US (47)