Wake Forest University Health Sciences
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.
Alzheimer Disease
l-Histidine
Control
PHASE4
The patients will be offered enrollment by sequential measures with odd numbers placed into the Control Group and even numbers in the Treatment Arm. One hundred patients will be enrolled in each arm. Study medications will be initiated in the outpatient setting following informed consent, enrollment and baseline lab evaluation. Scheduled clinic visits at 3 months and 1 year from date of enrollment will be used to re-assess performance via repeat cognitive testing. Lab evaluation of CBC, CMP, histidine and histamine levels will occur at baseline and the 3 month clinic visit for the treatment arm subjects. Group I: Control Arm- No intervention. Subjects will receive cognitive and lab testing and continue with current management of their cognitive impairment. Group II: Treatment Arm- In the outpatient setting, one chewable tablet multivitamin (Zn and folic acid containing) plus a titrated dosing of L-histidine powder or capsules starting at 2g consumed before noon escalating every 2 weeks up to 4, 6, then 8 g per day as tolerated.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 200 participants |
| Masking : | TRIPLE |
| Primary Purpose : | TREATMENT |
| Official Title : | Histidine Oral Supplementation as a Therapeutic Modality for Alzheimer's Disease |
| Actual Study Start Date : | 2024-12 |
| Estimated Primary Completion Date : | 2026-04 |
| Estimated Study Completion Date : | 2026-04 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 50 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157