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Anti-metabolites

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)

Must not have

A current active, uncontrolled seizure disorder

A current diagnosis of uncontrolled Type I or Type II diabetes mellitus, as defined by Hemoglobin A1C (Hb A1C ≥ 8)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 weeks

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.

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.

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

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I am between 50 and 89 years old.

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I have been diagnosed with early Alzheimer's disease.

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My memory and thinking test score is below 26.

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have seizures that are not controlled by medication.

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My diabetes is not well-controlled, with an HbA1C level of 8 or higher.

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I have not taken Benfotiamine in the last 3 months.

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I do not have a disability that would stop me from completing study tasks.

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I do not have Parkinson's, Huntington's, vascular dementia, CJD, LBD, PSP, AIDS, or NPH.

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I do not have major neurological issues besides Alzheimer's disease.

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I started a treatment targeting brain amyloid less than 6 months ago.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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).

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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 / 13Eligibility criteria met