Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia

NCT05227820 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Biovie & Dementia
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Clinical Dementia Rating Change as Calculated From the Quick Dementia Rating Scale Change

  3 Months

• Montreal Cognitive Assessment (MoCA) Change

  3 Months

• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Change

  3 Months

• Mini-Mental State Examination (MMSE) Change

  3 Months

Study Arms (1)

Experimental Arm: NE3107

EXPERIMENTAL

All participants will take 200mg BID (12 hours apart) of NE3107 for 3 months.

Drug: NE3107

Interventions

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)

Experimental Arm: NE3107

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead
• BioVie Inc.: collaborator

Study Sites (1)

Neurological Associates - The Interventional Group

Santa Monica, California, 90403, United States

Location

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MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Research Coordinator
• Organization: The Regenesis Project

jharoon@theneuroassociates.com

(989) 245-9205

Study Officials

• Sheldon Jordan

  Neurological Associates The Interventional Group/The Regenesis Project

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: February 7, 2022
• Study Start: January 19, 2022
• Primary Completion: July 20, 2022
• Study Completion: August 20, 2022
• Last Updated: July 9, 2024
• Results First Posted: July 9, 2024

Record last verified: 2024-07

Locations

US (1)