Olfactory Training for Mild Cognitive Impairment

(OTMCI Trial)

Overseen By Jeffrey N Motter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Must not be taking: Asthma medications

Disqualifiers: Dementia, Neurological disorders, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 51

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if "Olfactory Training" (a therapy using smell exercises) can help individuals with mild cognitive impairment (MCI) improve their sense of smell, thinking skills, and daily functioning. MCI is an early stage of memory loss that often precedes Alzheimer's disease. Participants will be randomly assigned to either smell memory exercises or visual memory exercises for three months, with a follow-up at six months. The trial seeks individuals with MCI who notice memory issues in their daily life. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance daily life for those with MCI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on nasally administered medications other than nasal steroids, you may not be eligible to participate.

What prior data suggests that olfactory training is safe for improving smell and thinking abilities?

Previous studies have shown that olfactory training can improve brain function and thinking skills. This training involves regularly smelling different scents. Research indicates that it can enhance thinking skills in individuals, regardless of their initial sense of smell.

The treatment appears well-tolerated, with no major safety issues reported. Participants undergoing olfactory training have not experienced significant negative effects, suggesting that the treatment is generally safe, even for those with mild memory or thinking problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about olfactory training for mild cognitive impairment because it offers a non-invasive approach to potentially boost cognitive function. Unlike standard treatments which primarily use medications like cholinesterase inhibitors to manage symptoms, olfactory training targets the brain's ability to process and recall smells, which is often one of the first senses affected in cognitive decline. By stimulating the olfactory pathways, this method could enhance memory and cognitive abilities without the side effects associated with many drugs. Additionally, the trial also includes visual memory training, providing a unique comparison of sensory-based cognitive interventions.

What evidence suggests that olfactory training could be effective for mild cognitive impairment?

This trial will compare Olfactory Memory Training with Visual Memory Training for individuals with mild cognitive impairment (MCI). Research has shown that smell training can help people regain their sense of smell. Although strong evidence is lacking that this training significantly improves thinking or memory in people with MCI, losing the sense of smell is a well-known early sign of Alzheimer's. Some studies suggest that using smell training to engage the brain might benefit mental health. Early research has shown positive effects, but further studies are needed to confirm these findings. If successful, this method could aid in early intervention for those at risk of Alzheimer's. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeffrey N Motter, PhD

Principal Investigator

Research Foundation for Mental Hygiene, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals aged 55-89 with mild cognitive impairment (MCI), who have memory or other cognitive complaints and score below certain levels on a memory test. They must have an informant to provide updates on their functioning.

Inclusion Criteria

I have noticed problems with my memory or other thinking skills.

I have been diagnosed with mild cognitive impairment based on memory tests.

My thinking and memory test score is 17 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Olfactory Memory Training or Visual Memory Training for 3 months

12 weeks

48 training sessions at home

Follow-up

Participants are monitored for changes in cognitive, olfactory, and functional measures

3 months

Visits at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Olfactory Training

Trial Overview The study tests if 'Olfactory Training' can improve the sense of smell, thinking abilities, and daily function in MCI patients compared to 'Visual Memory Training'. Participants are randomly assigned to one of these two training methods for three months.

How Is the Trial Designed?

Group I: Olfactory Memory Training Active Control 1 Intervention

Group II: Visual Memory Training Active Control 1 Intervention

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Jeffrey Motter

Lead Sponsor

Trials

1

Recruited

30+

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352155/

Assessing modified olfactory training to prevent cognitive ... Initial studies indicate that modified olfactory training (MOT) may yield superior outcomes compared to COT. Thus, this study aims to evaluate ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06825403

Olfactory Training in Mild Cognitive Impairment This study will attempt to determine if olfactory training is a useful for improving smell abilities, thinking abilities, and everyday functioning by examining ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0167494324001018

The role of olfactory dysfunction in mild cognitive ... This comprehensive meta-analysis investigates the association between olfactory deficits in mild cognitive impairment (MCI) and Alzheimer's disease (AD).

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/psyg.70093

Effectiveness of Olfactory Training for Cognition and ... The OT did not significantly improve global cognition (SMD = 0.65; 95% CI −0.37 to 1.67) or verbal fluency (SMD = 0.06; 95% CI −0.22 to 0.34).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9891899/

Does Olfactory Training Improve Brain Function and Cognition ... Across all five studies, there is convergent findings that indicate OT in adults with and without olfactory loss at baseline can cognitively ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70120

Mind your nose: A randomized controlled trial of olfactory ... Our study supports the broadening of olfactory training beyond odor exposure to target cognitive processes such as memory through a multi-modal ...