Status:
COMPLETED
Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia
Lead Sponsor:
Neurological Associates of West Los Angeles
Collaborating Sponsors:
BioVie Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-89 years
Phase:
PHASE2
Brief Summary
This study seeks to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Alzheimer's disease and inflammatory and metabolic parameters that can be measur...
Detailed Description
Considering how many people are in a state of mild cognitive impairment (MCI) and frank dementia, there is a substantial cost to society in terms of financial burden and suffering. Degenerative condit...
Eligibility Criteria
Inclusion
- In order for a subject to be considered for this study, the following criterion is required:
- Cognitive decline with Clinical Dementia Rating (CDR) score of 0.5 to 1, suggesting mild cognitive impairment to mild dementia.
- Participants must be between the ages of 50-89
- Primary cognitive complaint must be memory Impairment without movement or psychiatric explanation/diagnosis
- Participants must show at least one abnormal imaging biomarker and none of the exclusion criteria below.
Exclusion
- In order for a subject to be considered for this study, he/she may NOT have any of the following:
- Subjects with contraindications for lumbar puncture, such as bleeding abnormalities, use of anticoagulant medications, and local skin or spine abnormalities
- Reversible causes of cognitive impairment that explains the clinical status entirely, such as hypothyroidism, depression
- Advanced stages of any terminal illness or any active cancer that requires chemotherapy
- History of breast cancer
- Women with child-bearing potential who are not willing to use a double-barrier birth control method
- Males not willing to use a double-barrier birth control method with female sex partners with child-bearing potential
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05227820
Start Date
January 19 2022
End Date
August 20 2022
Last Update
July 9 2024
Active Locations (1)
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1
Neurological Associates - The Interventional Group
Santa Monica, California, United States, 90403