Smell memory training for people with mild cognitive impairment
Official title: Olfactory Training in Mild Cognitive Impairment
Run by New York State Psychiatric Institute · NCT06825403 · Data updated 2026-11-12
This trial will test whether a home-based smell memory training program helps people aged 55–89 with mild cognitive impairment improve their sense of smell and thinking skills.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 89 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | New York State Psychiatric Institute Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | August 7, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT06825403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 55–89 with subjective cognitive complaints, a MoCA score of at least 17, and objective mild cognitive impairment defined by education-adjusted delayed paragraph recall cutoffs on the WMS-III Logical Memory test.
✕Probably not a fit
People with more advanced dementia, severe non-neurodegenerative smell loss (e.g., recent nasal injury), those outside the age or cognitive criteria, or unable to complete home sessions or clinic visits are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will recruit 30 patients with mild cognitive impairment and randomize them to three months of olfactory memory training or an active visual memory training control. Participants will complete 48 home sessions of about 10 minutes each, and undergo cognitive, olfactory, and daily function testing at baseline, 3 months, and 6 months. The olfactory training uses paired odor-matching tasks with commercially available scented materials, while the control uses matching of abstract visual symbols. The study is single-site at the New York State Psychiatric Institute and focuses on feasibility and preliminary efficacy.
Why it matters
Potential benefit: If successful, this low-cost, at-home training could improve smell ability and potentially support memory or everyday cognitive function in people with MCI.
How similar studies have gone: Previous olfactory training studies have improved smell ability in other forms of smell loss and some meta-analyses suggest cognitive benefits, but application specifically to MCI has been limited and is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 55-89 at the time of informed consent. 2. Montreal Cognitive Assessment score \>=17. 3. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language. 4. Meets criteria for cognitive impairment (CI), including either early mild cognitive impairment (eMCI) or late mild cognitive impairment (lMCI), defined as memory function documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Story A, Delayed Paragraph Recall) from the Wechsler Memory Scale (WMS) - III (the maximum score is 25). The criteria for MCI (includes eMCI and lMCI) are as follows: eMCI is defined by a WMS-III Logical memory delayed recall score of 3-6 with 0-7 years of education, score of 5-9 with 8-15 years of education, and score of 9-11 with 16 or more years of education. lMCI is defined by a WMS-III Logical Memory delayed recall score ≤ 2 with 0-7 years of education, score ≤ 4 with 8-15 years of education, and score ≤ 8 with ≥ 16 years of education. 5. An informant (relative, friend, other caregiver) who contacts the participant at least weekly is required to provide information about the participant's functioning. If the informant drops out, an alternate informant can be designated by the participant. Exclusion Criteria: 1. Diagnosis of dementia of any type. 2. Neurological disorders including Parkinson's disease, Huntington's disease, multiple sclerosis, stroke, epilepsy, traumatic brain injury (moderate to severe, with greater than 30 min loss of consciousness), and other neurologic disorders with focal signs (e.g., amyotrophic lateral sclerosis). 3. Current clinical diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, alcohol use disorder, or substance use disorder (Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-Text Revision criteria). 4. Current unstable or untreated major depression, Geriatric Depression Scale (Short Form) score \>= 6, or active suicidality based on a suicide scale (Columbia-Suicide Severity Rating Scale Screen version: positive answer to question 1 or 2 followed by item 6 positive answer leads to exclusion. Negative answer to questions 1 and 2: interview ends and the participant is not excluded for active suicidality). 5. Acute, severe unstable medical illness in the judgment of the clinician. For cancer, acutely ill participants (including those with metastases) are excluded, but history of successfully treated cancer does not result in exclusion. 6. Participation concurrently in another therapeutic clinical trial of a cognitive enhancing drug or device or procedure. 7. Current upper respiratory infection (participant rescheduled as soon as this improves), current smoker \>1 pack daily (past smoking has been shown not to affect odor identification scores), self-reported congenital anosmia. 8. Severe vision, hearing, or tactile impairment that would prevent the participant from performing the cognitive tests accurately. This will be a clinical determination. 9. History of severe or recent asthma (defined as use of an inhaler for asthma, use of other asthma medication, or occurrence of an asthma attack within the last ten years), known special sensitivities to volatile chemicals, anyone who believes she is pregnant or is nursing a baby, and anyone who is on nasally administered medications other than people on nasal steroids to control rhinitis, allergic and otherwise. 10. Sino-nasal Outcome Test-22 nasal domain score \>21, or individual score = 5, representing severe nasal symptoms that interfere with olfaction. 11. Allergies to any odors used in the olfactory testing or olfactory memory training.
Where it's running
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New York State Psychiatric Institute
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Jeffrey N Motter, PhD — Research Foundation for Mental Hygiene, Inc.
- Study coordinator: Jeffrey N Motter, PhD
- Email: jeffrey.motter@nyspi.columbia.edu
- Phone: 6467748654
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.