← Back to Search

Anti-metabolites

High Dose Benfotiamine for Alzheimer's Disease

Phase 2

Recruiting

Led By Howard Feldman, MDCM

Research Sponsored by Alzheimer's Disease Cooperative Study (ADCS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

Awards & highlights

Study Summary

"This trial aims to investigate whether a drug called Benfotiamine is safe and effective in delaying the progression of early Alzheimer's disease symptoms."

Who is the study for?

This trial is for individuals aged 50-89 with early Alzheimer's, confirmed by specific biomarkers. They must be able to walk (with assistance if needed), have a certain level of cognitive function, and speak English or Spanish. Women should be post-menopausal or surgically sterile. Participants need a committed study partner and may take stable Alzheimer's medications.Check my eligibility

What is being tested?

The BenfoTeam trial is testing the safety and effectiveness of Benfotiamine in slowing down early Alzheimer's symptoms. It involves comparing a placebo with low and high doses of Benfotiamine to see which works better at delaying symptom progression.See study design

What are the potential side effects?

While the side effects are not detailed here, typically, clinical trials monitor for any adverse reactions ranging from mild discomforts like headaches or nausea to more serious issues depending on how the body reacts to the new medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 50 and 89 years old.

Select...

I have been diagnosed with early Alzheimer's disease.

Select...

My memory and thinking test score is below 26.

Select...

I have been on a stable dose of Alzheimer's medication for at least 3 months.

Select...

I can walk on my own or with help from a device.

Select...

I am a woman who has been post-menopausal for at least a year or have been surgically sterile for 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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).

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).

Secondary outcome measures

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

Mean and Median Thiamine Monophosphate (ThMP) levels (nmol/L).

Mean and Median Thiamine levels (nmol/L).

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose BenfotiamineExperimental Treatment1 Intervention

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

Group II: High Dose BenfotiamineExperimental Treatment1 Intervention

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

Group III: PlaceboPlacebo Group1 Intervention

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Burke Medical Research InstituteOTHER

23 Previous Clinical Trials

1,059 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,684 Previous Clinical Trials

28,025,435 Total Patients Enrolled

Alzheimer's Disease Cooperative Study (ADCS)Lead Sponsor

24 Previous Clinical Trials

6,327 Total Patients Enrolled

Frequently Asked Questions

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

Does this medical study include individuals who are older than 45 years of age?

"Participants aged 50 years or older but younger than 89 are being sought for recruitment in this trial."

Answered by AI

Are individuals currently being enrolled in this ongoing medical study?

"Per information on clinicaltrials.gov, this current medical trial is actively pursuing participants. The study was initially shared with the public on March 22nd, 2024 and last revised on April 29th of the same year."

Answered by AI

How many individuals are enrolled as participants in this ongoing medical study?

"Indeed, as per the details on clinicaltrials.gov, this research study is presently seeking eligible candidates. The trial was initially published on March 22, 2024 and underwent its latest update on April 29, 2024. A total of 406 participants are sought across eleven distinct sites."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"Conducted at Brain Matters Research (Kane Center) in Stuart, Iowa, the University of Iowa in Iowa City, Illinois, and Southern Illinois University in Springfield, Kentucky among 11 additional sites."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The key focus of this research, spanning approximately 72 weeks, is Phase 2B. The primary goal involves assessing cognitive changes in participants from baseline to the end of the study at week 72 using the Alzheimer's disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13) and comparing outcomes between those receiving benfotiamine treatment and those on a placebo. Additional objectives include monitoring participant withdrawals from the trial for any reasons during this period, tracking drug discontinuations among participants, as well as analyzing thiamine levels both mean and median (nmol/L) in blood samples taken from all individuals enrolled. Th"

Answered by AI

What is the safety profile of High Dose Benfotiamine in individuals undergoing treatment?

"Scoring a 2 on our safety assessment scale, the high dose of Benfotiamine is being assessed in this Phase 2 trial. Presently, there exists some data supporting its safety profile; however, no efficacy-related data has been documented yet."

Answered by AI

Am I eligible to participate in this clinical investigation?

"This study aims to recruit 406 individuals aged between 50 and 89 diagnosed with Alzheimer's disease, meeting the following conditions: Age range of 50 to 89 during initial assessment, Presence of a confirmed plasma AD biomarker profile, Proficiency in English or Spanish for effective communication during cognitive evaluations and study visits, Ability to walk independently or with aid as needed., Clinical Dementia Rating (CDR) global score of either 0.5 or 1 along with a memory subscore equal to or greater than 0.5 at screening, Post-menopausal status for female candidates lasting over one year, sterilization via bilateral"

Answered by AI