Company: JUNS
Filing Date: 2025-11-26
Form Type: S-1
Source: 0001493152-25-025204
Chunk: 153

Company: JUPITER NEUROSCIENCES, INC.
Filing Date: 2025-11-26
Form: S-1
Chunk 153
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 found by the FDA to
be safe and tolerable in individuals with MCI/early AD.

Objectives

Primary Objective:

| ● | To determine the safety and efficacy                                                 
 of JOTROL™ (200 mg resveratrol BID and 500 mg resveratrol BID) for neuroinflammation 
 and biomarkers of MCI/early AD.                                                      |

| ● | To assess safety and tolerability                                                          
 of JOTROL™ in AD-MCI patients by monitoring adverse events (AEs) and serious               
 adverse events (“SAEs”) and assessing their relationship to the study drug. Tolerability   
 will be measured by subjects’ ability to remain on treatment. Overall tolerability         
 of the drug will be defined as fewer than 25% discontinuations due to drug-related AEs and 
 SAEs                                                                                       |

| ● | A first efficacy indicator will be stabilization of Abeta 40/42. |

| 86 |

Secondary Objectives:

| ● | To assess population pharmacokinetics (“Population PK”) in the ITT population |

| ● | To measure the effect of JOTROL™                                                          
 on biochemical markers for AD, neurodegeneration, vascular damage, metabolic effects, and 
 neuroinflammation                                                                         |

| ● | To determine the effects of JOTROL™       
 on whole-brain and regional brain atrophy |

| ● | To measure the effects of JOTROL™ 
 on functional MRI measures        |

| ● | To assess cognitive effects of JOTROL™ |

| ● | To examine the influence of Apolipoprotein E genotyping on both biomarker and cognitive endpoints |

Endpoints

Primary Endpoint:

| ● | Assessment of safety/tolerability by monitoring AEs and SAEs, assessing their potential relationship to 
 the study drug and Abeta 40/42                                                                          |

Secondary Endpoints:

| ● | Levels of AD relevant biomarkers |

| ● | Volumetric MRI and Cortical Disarray Measurement |

| ● | Additional experimental biomarkers as stated in protocol, such as those for neuroinflammation |

Study Population: Approximately
105 male or female subjects between 55 and 85 years of age with a diagnosis of MCI/early AD will be enrolled. MCI/early AD patients should
be amyloid positive with an AD/MCI clinical diagnosis.

Phase: Phase II Description
of Sites/Facilities Enrolling Participants: Approximately 8 study centers in the USA. Study sites will be determined by competitive selection