Histidine Supplementation for Alzheimer's Disease

Overseen By Wells Reynolds, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Psychiatric

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

Oral supplementation of histidine in patients with cognitive dysfunction should increase brain anserine, carnosine and histamine levels which will result in improved cognition via numerous proven in vivo mechanisms including increasing blood flow, neurogenesis, angiogenesis, activation of histaminergic neural pathways and autophagy of beta-amyloid protein, which is pathognomonic for Alzheimer's disease. Randomized into one of 2 arms to receive Histidine or placebo to take for up to 3 months. Baseline evaluation and followup evaluation at 3 months postop.

Who Is on the Research Team?

Wells Reynolds, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Live at home currently

I am 50 years old or older.

Clinical Dementia Score of 3.0 or higher

Exclusion Criteria

Psychiatric

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Histidine or placebo for up to 3 months, with titrated dosing of L-histidine in the treatment arm

3 months

Baseline evaluation, 3-month clinic visit

Follow-up

Participants are monitored for safety and effectiveness after treatment, with cognitive testing and lab evaluations

9 months

1-year clinic visit

What Are the Treatments Tested in This Trial?

Interventions

• Histidine Oral Supplementation

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment-Histidine Active Control 1 Intervention

Treatment-Histidine

Group II: Control Placebo Group 1 Intervention

Control

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+