Company: MIRA
Filing Date: 2025-06-17
Form Type: PREM14A
Source: 0001641172-25-015340
Chunk: 192

Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-06-17
Form: PREM14A
Chunk 192
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 with routine     
 life at home or work.                                                                        |

| ■ | Mild                                                                                              
 impairment shown on cognitive tests: Standardized screening tools — such as the                   
 Short Test of Mental Status, the Montreal Cognitive Assessment (MoCA), or the Mini-Mental         
 State Examination (MMSE), may reveal subtle deficits appropriate to age and education level.      
 More comprehensive neuropsychological testing can help determine the extent and type of cognitive 
 impairment.                                                                                       |

| ■ | Does                                                                                     
 not meet criteria for dementia: While MCI involves cognitive decline, the symptoms are   
 not severe enough to qualify as dementia, including Alzheimer’s disease or other related 
 conditions.                                                                              |

Early identification and monitoring are key in managing MCI, especially to assess the potential risk of progression to more serious cognitive disorders.

Pharmaceutical Treatments of MCI

Currently, there is no FDA-approved medication specifically for Mild Cognitive Impairment (MCI). However, a few drugs are sometimes used off-label—especially when MCI is suspected to be an early stage of Alzheimer’s disease. Here’s a breakdown of medications that may be used for MCI, particularly in clinical or off-label contexts:

| Drug         
 Name         |     | Brand    
 Name     |     | Purpose                                                        |
| Donepezil    |     | Aricept  |     | Enhances                                                       
 acetylcholine to support memory and learning                   |
| Rivastigmine |     | Exelon   |     | Like                                                           
 donepezil; also approved for Parkinson’s dementia              |
| Galantamine  |     | Razadyne |     | Modulates                                                      
 nicotinic receptors as well as inhibiting acetylcholinesterase |

Emerging & Experimental Drugs (Under Investigation)

Anti-Amyloid Therapies for MCI and Mild Alzheimer’s Disease 5:

Lecanemab (brand name: Leqembi)is the first anti-amyloid therapy to demonstrate clear clinical benefit in individuals with Mild Cognitive Impairment (MCI) and mild Alzheimer’s disease. The drug, previously known as BAN2401, received accelerated approval from the U.S. Food and Drug Administration (FDA) on January 6, 2023, based on evidence from surrogate endpoints—specifically the reduction of beta-amyloid plaques—that are reasonably likely to predict clinical benefit.

5https://memory.georgetown.edu/news/lecanumab-leqembitm-fda-approved-for-individuals-with-mild-cognitive-