Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169826
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-12-04
Brief Title:
Histidine Oral Supplementation as a Therapeutic Modality for Alzheimers Disease
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Histidine Oral Supplementation as a Therapeutic Modality for Alzheimers Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Alzheimers 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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None