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Histidine Supplementation for Alzheimer's Disease

Phase 4
Waitlist Available
Led By Wells Reynolds, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>49 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial seeks to improve cognition by increasing brain Histidine, Anserine & Carnosine via oral Histidine supplementation in patients with cognitive dysfunction.

Who is the study for?
This trial is for individuals with Alzheimer's Disease who are interested in testing whether a dietary supplement, l-Histidine, can improve their cognitive function. Participants will be randomly assigned to receive either the Histidine supplement or a placebo for three months.
What is being tested?
The study is examining if taking l-Histidine orally can boost brain health and cognition in Alzheimer's patients by increasing certain substances that may help blood flow and brain repair. Patients will take the supplement or placebo over three months with evaluations before and after.
What are the potential side effects?
Potential side effects of l-Histidine supplementation could include allergic reactions, gastrointestinal issues like nausea or upset stomach, headaches, dizziness, or changes in energy levels. However, specific side effects related to this trial have not been detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Dementia Rating
Secondary study objectives
Histidine blood levels

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment-HistidineActive Control1 Intervention
Treatment-Histidine
Group II: ControlPlacebo Group1 Intervention
Control

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,398 Previous Clinical Trials
2,460,010 Total Patients Enrolled
Wells Reynolds, MDPrincipal InvestigatorWake Forest University Health Sciences
~133 spots leftby Apr 2026
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