Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-22
Brief Title:
RQC for the Prevention of Alzheimers Disease and Retinal Amyloid-β
Sponsor:
Zaparackas and Knepper LTD
Organization:
Zaparackas and Knepper LTD
Study Overview
Official Title:
A Randomized Phase II Study to Evaluate Oral RQC for the Prevention of Alzheimers Disease and Retinal Amyloid-β
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The goal of this clinical trial is to evaluate whether oral resveratrol quercetin and curcumin RQC can prevent the accumulation of retinal amyloid-β andor cognitive decline over 24 months in adults aged 50-90 with Stage 1 or 2 Alzheimers disease as described in FDA-2013-D-0077 The trial will also evaluate the safety and tolerability of RQC Curcumin which binds to amyloid-β will act as a fluorescent label to identify retinal amyloid-β in vivo using optical coherence tomography OCT-autofluorescence imaging The investigators will longitudinally evaluate the effect of RQC on retinal amyloid-β load cognitive outcomes including the Clinical Dementia Rating Scale Sum of Boxes CDR-SB and the Mini Mental State Examination MMSE and potential microvascular biomarkers The investigators will also evaluate associations between retinal amyloid-β and progression to early Alzheimers disease mild cognitive impairment The investigators will compare RQC taken daily for 24 months with curcumin alone taken only during the 7 days preceding each of the six study visits to see if RQC can prevent or reduce amyloid-β and prevent the onset of mild cognitive impairment
Detailed Description:
None
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