Anti-Inflammatory, Insulin-Sensitizing Agent for Treatment of Cognitive Decline Due to Degenerative Dementias
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change in fMRI
Study Overview
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 measure in the central nervous system (CNS) with advanced neuroimaging techniques in patients treated with NE3107 (17a-ethynyl-androst-5-3b,7b,17b-triol).
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 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 show at least one abnormal imaging biomarker and none of the exclusion criteria below.
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
Arms & Interventions
Experimental Arm: NE3107
All participants will take 200mg BID (12 hours apart) of NE3107 for 3 months.
Intervention: NE3107 (Drug)
Outcomes
Primary Outcomes
Change in fMRI
Time Frame: 3 Months
Primary endpoints assessed changes from baseline in neurophysiological health and oxidative stress using advanced neuroimaging analyses. Analysis methods utilized blinded expert evaluation between baseline and completion scans.
Secondary Outcomes
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Change(3 Months)
- Mini-Mental State Examination (MMSE) Change(3 Months)
- Clinical Dementia Rating Change as Calculated From the Quick Dementia Rating Scale Change(3 Months)
- Montreal Cognitive Assessment (MoCA) Change(3 Months)