NCT05122598

Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease

Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Evon Medics LLC · Industry
• Sex: All
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether daily treatment with this new treatment approach, called COT would be effective in protecting the memory and brain regions of people who are already showing signs of memory loss.

Detailed description

Alzheimer's disease process starts in parts of the brain used for perceiving and interpreting smell many years before people begin to lose their memory and other cognitive functions. These parts of the brain are called the "olfactory regions." From these olfactory regions, Alzheimer's disease spread to involve other parts of the brain. Scientists have shown that stimulating the olfactory regions through exposure to multiple naturally occurring essential or plant oils help to reduce the brain changes of Alzheimer's disease in animals. Also, many components from these plant oils have been shown to protect nerve cells from various kinds of stress and injuries; and we say they are 'neuroprotective'. A novel home-based olfactory chemosensory stimulation program that uses a portable, programmed, device known as the Computerized Olfactory Training (COT) program, administers olfactory psychophysical tasks while patients are being stimulated repeatedly with neuroprotective olfactory stimulants, using neuroscience-guided stimulation parameters to ensure sustained activation of all primary and secondary olfactory structures.

Conditions

• Mild Cognitive Impairment
• Early Alzheimer's Disease
• Memory Impairment

Interventions

Type	Name	Description
DRUG	COT	The COT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.
DRUG	Sham	Sham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks.

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-04-01
• Completion: 2023-04-30
• First posted: 2021-11-17
• Last updated: 2022-05-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study