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| Name | Class |
|---|---|
| BioVie Inc. | INDUSTRY |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm: NE3107 | Experimental | All participants will take 200mg BID (12 hours apart) of NE3107 for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NE3107 | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in fMRI | 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. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Dementia Rating Change as Calculated From the Quick Dementia Rating Scale Change | Quick Dementia Rating Scale (QDRS) The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). |
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In order for a subject to be considered for this study, the following criterion is required:
Inclusion Criteria:
Exclusion Criteria:
In order for a subject to be considered for this study, he/she may NOT have any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Sheldon Jordan | Neurological Associates The Interventional Group/The Regenesis Project | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurological Associates - The Interventional Group | Santa Monica | California | 90403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17251419 | Background | Lacor PN, Buniel MC, Furlow PW, Clemente AS, Velasco PT, Wood M, Viola KL, Klein WL. Abeta oligomer-induced aberrations in synapse composition, shape, and density provide a molecular basis for loss of connectivity in Alzheimer's disease. J Neurosci. 2007 Jan 24;27(4):796-807. doi: 10.1523/JNEUROSCI.3501-06.2007. | |
| 30231623 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Arm: NE3107 | All participants will take 20mg BID (12 hours apart) of NE3107 for 3 months. 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Arm: NE3107 | All participants will take 20mg BID (12 hours apart) of NE3107 for 3 months. 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in fMRI | 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. | Posted | Count of Participants | Participants | 3 Months |
|
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Adverse event data were collected during the treatment period (day 1-90), and the follow up period (day 91-115)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Arm: NE3107 | All participants will take 20mg BID (12 hours apart) of NE3107 for 3 months. 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Lipase | Blood and lymphatic system disorders | Systematic Assessment | one participant showed evidence at one time point of elevated lipase on safety labs. Labs returned to normal on follow up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Research Coordinator | The Regenesis Project | (989) 245-9205 | jharoon@theneuroassociates.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2021 | Jun 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 3 Months |
| Montreal Cognitive Assessment (MoCA) Change | The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status. | 3 Months |
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Change | The ADAS-Cog evaluates participants' cognitive ability. It is composed of 11 parts that measure word recall, object/figure naming, command following, constructional praxis, ideational praxis, orientation, word recognition, test direction recall, spoken language, comprehension, and word-finding difficulty. The ADAS-Cog is scored from 0-70 by measuring the errors made in each task, with a score of 70 representing the most severe impairment. A point reduction of 3.1 to 3.8 has been found to be the minimal clinically important difference (Schrag & Schott, 2012). A change will be evaluated from baseline to completion. | 3 Months |
| Mini-Mental State Examination (MMSE) Change | The MMSE is a 30-point questionnaire that evaluates cognition. The MMSE includes specific tasks that assess orientation, attention, memory, language, and visual-spatial skills. MMSE scores range from 0 - 30 possible points; 0-17: severe cognitive impairment, 18-23: mild cognitive impairment, 24-30: no cognitive impairment. A point decrease >/= to 3 on the MMSE has been identified as the minimally clinically important difference (Andres, 2019). A change will be evaluated from baseline to completion. | 3 Months |
| Connolly S. Economics of dementia: A review of methods. Dementia (London). 2020 Jul;19(5):1426-1440. doi: 10.1177/1471301218800639. Epub 2018 Sep 19. |
| Background | Khan, T.K. (2016) Chapter 1 - introduction to Alzheimer's disease biomarkers. Biomarkers in Alzheimer's Disease, pp. 3-23. doi:10.1016/B978-0-12-804832-0.00001-8 |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Clinical Dementia Rating Change as Calculated From the Quick Dementia Rating Scale Change | Quick Dementia Rating Scale (QDRS) The Quick Dementia Rating Scale (QDRS) is an interview-based tool administered by study officials to participants' caregivers used to obtain observations from a consistent source. The QDRS form consists of 10 categorical questions (5 cognitive, 5 functional), each with 5 detailed options depicting the level of impairment as either 0 (normal), 0.5 (mild/inconsistent impairment), 1 (mild/consistent impairment), 2 (moderate impairment), or 3 (severe impairment). Based on the conversion table outlined in Dr. James Galvin's research (2015), total QDRS scores were converted to Clinical Dementia Rating (CDR) scale levels ranging from 0 (normal aging), 0.5 (mild cognitive impairment), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Montreal Cognitive Assessment (MoCA) Change | The MoCA evaluates frontal-executive functions (e.g., verbal abstraction and mental calculation), language (e.g., confrontation naming, phonemic fluency), orientation (e.g., person, place, date, day of the week, and time), visuospatial construction (e.g., simple figure copy), divided visual attention, and immediate and delayed memory of unstructured information. MoCA scores range from 0-30 possible points; 26 or greater is considered to reflect normal cognitive status. | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Change | The ADAS-Cog evaluates participants' cognitive ability. It is composed of 11 parts that measure word recall, object/figure naming, command following, constructional praxis, ideational praxis, orientation, word recognition, test direction recall, spoken language, comprehension, and word-finding difficulty. The ADAS-Cog is scored from 0-70 by measuring the errors made in each task, with a score of 70 representing the most severe impairment. A point reduction of 3.1 to 3.8 has been found to be the minimal clinically important difference (Schrag & Schott, 2012). A change will be evaluated from baseline to completion. | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| Secondary | Mini-Mental State Examination (MMSE) Change | The MMSE is a 30-point questionnaire that evaluates cognition. The MMSE includes specific tasks that assess orientation, attention, memory, language, and visual-spatial skills. MMSE scores range from 0 - 30 possible points; 0-17: severe cognitive impairment, 18-23: mild cognitive impairment, 24-30: no cognitive impairment. A point decrease >/= to 3 on the MMSE has been identified as the minimally clinically important difference (Andres, 2019). A change will be evaluated from baseline to completion. | Posted | Count of Participants | Participants | 3 Months |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 8 |
| 23 |
|
| Dizziness | General disorders | Systematic Assessment | One patient reported dizziness during a study check in |
|
| Dry Mouth | General disorders | Systematic Assessment | One patient reported a dry mouth in a regular study check up |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment | One patient demonstrated a lab value indicating a urinary tract infection following a safety lab visit. Patient recovered after antiviral treatment. |
|
| Tachycardia | Cardiac disorders | Systematic Assessment | One patient demonstrated an elevated heart rate at a study safety visit |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | One patient reported having suffered and recovered from a bout of diarrhea at a study check in |
|
| COVID-19 Infection | Infections and infestations | Systematic Assessment | One patient experienced an infection with the COVID-19 virus during the trial. |
|
| Knee Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | One patient reported having tripped and injured their knee during the trial. |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |