Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia
NCT ID: NCT05227820
Last Updated: 2024-07-09
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
23 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-01-19
Study Completion Date
2022-08-20
Brief Summary
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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 measure in the central nervous system (CNS) with advanced neuroimaging techniques in patients treated with NE3107 (17a-ethynyl-androst-5-3b,7b,17b-triol).
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Detailed Description
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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 conditions that result in cognitive change in middle and late life are frequently associated with abnormal deposits of protein material (e.g., amyloid, phospho-tau) which interfere with neuronal function and viability. Inflammation and insulin resistance in the CNS and abnormal protein deposition and resultant physiological impairment characterize conditions of the Alzheimer's dementia (AD) type.
Neuroinflammation prompts AD progression, impaired cholesterol efflux and reduced insulin signaling (insulin resistance). Insulin resistance has been considered a risk factor as well as a feature of AD, and has also been associated with increased aß-42 secretion, neuritic plaque burden, abnormal insulin receptor performance, decreased glucose metabolism, and consequently decreased cognitive performance.
No therapy exists that has been proven to halt or reverse the progressive deposition of abnormal proteins or the attendant neurophysiological deterioration. Various investigational therapies aim to target the pathophysiological processes of AD; from combating abnormal protein deposition, to targeting sources of systemic and neuroinflammation, to providing cholinergic, hormonal, and metabolic support. A promising area of research is the ongoing use of insulin synthesizers as a therapeutic option for AD.
Several Phase 3 studies have been initiated and/or completed with compounds such as Semaglutide, a hormone that stimulates insulin signaling, Metformin, an insulin synthesizer, and NE3107, an anti-inflammatory insulin-sensitizing agent.
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 measured in the CNS with advanced neuroimaging techniques in patients treated with NE3107 (17a-ethynyl-androst-5-ene-3b,7b,17b-triol).
Investigational Product
The drug under investigation is NE3107 (17a-ethynyl-androst-5-ene-3b,7b,17b-triol). NE3107 is formulated with common excipients used in oral medications in #2 hard gelatin capsules. The capsules are designed for oral administration. NE3107 capsules are stable at room temperature for at least 18 months. Stability of the capsules used in this study will be monitored by a concurrent stability study conducted by the capsule manufacturer and the holder of the primary IND, Biovie, Inc (Santa Monica, CA).
Neuroinflammation prompts AD progression, impaired cholesterol efflux and reduced insulin signaling (insulin resistance). Insulin resistance has been considered a risk factor as well as a feature of AD, and has also been associated with increased aß-42 secretion, neuritic plaque burden, abnormal insulin receptor performance, decreased glucose metabolism, and consequently decreased cognitive performance.
No therapy exists that has been proven to halt or reverse the progressive deposition of abnormal proteins or the attendant neurophysiological deterioration. Various investigational therapies aim to target the pathophysiological processes of AD; from combating abnormal protein deposition, to targeting sources of systemic and neuroinflammation, to providing cholinergic, hormonal, and metabolic support. A promising area of research is the ongoing use of insulin synthesizers as a therapeutic option for AD.
Several Phase 3 studies have been initiated and/or completed with compounds such as Semaglutide, a hormone that stimulates insulin signaling, Metformin, an insulin synthesizer, and NE3107, an anti-inflammatory insulin-sensitizing agent.
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 measured in the CNS with advanced neuroimaging techniques in patients treated with NE3107 (17a-ethynyl-androst-5-ene-3b,7b,17b-triol).
Investigational Product
The drug under investigation is NE3107 (17a-ethynyl-androst-5-ene-3b,7b,17b-triol). NE3107 is formulated with common excipients used in oral medications in #2 hard gelatin capsules. The capsules are designed for oral administration. NE3107 capsules are stable at room temperature for at least 18 months. Stability of the capsules used in this study will be monitored by a concurrent stability study conducted by the capsule manufacturer and the holder of the primary IND, Biovie, Inc (Santa Monica, CA).
Conditions
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Alzheimer Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Experimental Arm: NE3107
All participants will take 200mg BID (12 hours apart) of NE3107 for 3 months.
Group Type
EXPERIMENTAL
NE3107
Intervention Type
DRUG
Participants will take 20mg twice daily (BID) approximately 12 hours apart. The dose will be stable the duration of the study intervention (3 months)
Interventions
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NE3107
Participants will take 20mg twice daily (BID) approximately 12 hours apart. The dose will be stable the duration of the study intervention (3 months)
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 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 be between the ages of 50-89
* Primary cognitive complaint must be memory Impairment without movement or psychiatric explanation/diagnosis
Exclusion Criteria
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
* 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
Minimum Eligible Age
55 Years
Maximum Eligible Age
89 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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BioVie Inc.
INDUSTRY
Sponsor Role
collaborator
Neurological Associates of West Los Angeles
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Sheldon Jordan
Role: PRINCIPAL_INVESTIGATOR
Neurological Associates The Interventional Group/The Regenesis Project
Locations
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Neurological Associates - The Interventional Group
Santa Monica, California, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Biovie & Dementia
Identifier Type: -
Identifier Source: org_study_id
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