ClinicalTrials.gg
RecruitingNCT06825403OTMCIUpdated Sep 4, 2026

Olfactory Training in Mild Cognitive Impairment

An interventional study of Olfactory Memory Training and Visual Memory Training in Mild Cognitive Impairment, sponsored by Jeffrey Motter. Recruiting at 1 site in United States. Open to participants aged 55 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Jeffrey Motter · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
55 Years to 89 Years
Sex
All
01

Study summary

Sense of smell tends to decline in individuals with early Alzheimer's disease, typically earlier than when other senses and thinking abilities begin to decline. Memory for new odors is particularly diminished in these individuals. Existing treatments for AD do not improve these symptoms. A targeted treatment for improving sense of smell, called 'Olfactory Training', has been used to improve sense of smell in people with various forms of smell loss, though it is not known whether it can improve smell abilities and thinking abilities in patients who are at high risk of developing Alzheimer's disease. The investigators will conduct a randomized clinical trial with patients who have mild cognitive impairment (MCI). This is an early phase of memory loss that is worse than normal aging and may precede Alzheimer's disease. Patients will be randomized to either olfactory memory training or visual memory training for 3 months, with a final follow-up visit at 6 months. This study will attempt to determine if olfactory training is a useful for improving smell abilities, thinking abilities, and everyday functioning by examining change in these outcomes over time.

Read the detailed description

There is an urgent and unmet need to develop interventions capable of improving cognition and everyday functioning in individuals at risk for cognitive decline. Olfactory training consists of systematic exposures to odors, with multiple reviews and meta-analyses concluding it has beneficial effects on cognition and olfaction. The application of olfactory training for preventing cognitive decline in MCI has received limited attention. The overarching goal of the research to be carried out in this application is to determine the feasibility and efficacy of Olfactory Memory Training (OMT) for patients with mild cognitive impairment (MCI). 30 patients with MCI will be recruited from the Memory Disorders Center at the New York State Psychiatric Institute and randomized to 3 months of OMT or active control training. OMT will involve an odor memory task, during which patients sample containers consisting of pairs of commercially available odors (flavored tea leaves). During each training session, non-descript containers are placed on a grid. On each trial, patients sample two containers, and attempt to find a match. The active control involves Visual Memory Training (VMT) with matching of abstract symbols rather than odors. Patients will complete 48 training sessions at home lasting approximately 10 minutes each. At baseline, 3 months, and 6 months follow-up, patients will complete a battery of cognitive, olfactory, and functional measures. In Aim 1, the investigators will compare change in cognitive (Preclinical Alzheimer Composite-5 [PACC5]) and olfactory functioning (Sniffin' Sticks Threshold, Discrimination, and Identification [TDI]) over 6 months in OMT versus VMT. In Aim 2, the investigators will compare change in everyday functioning (Alzheimer's Disease Cooperative Study-Activities of Daily Living scale - Prevention Instrument [ADCS-ADL-PI]) over 6 months in OMT versus VMT. If successful, this study has potential to develop a low-cost and scalable intervention. This study will inform the design of subsequent larger trials of OMT.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Olfactory Training
  • Olfactory Memory Training
  • Visual Training
  • Visual Memory Training
  • Olfaction
  • Memory Disorders
  • Cognitive Disorders
  • Cognitive Impairment
  • Mild Cognitive Impairment
  • Cognitive Training
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 30 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

This is the only study on the registry with Jeffrey Motter as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 55-89 at the time of .
  2. 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

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 ( (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 ) 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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Olfactory Memory Training

    Behavioral: Olfactory Memory Training

  • Active comparator
    Visual Memory Training

    Behavioral: Visual Memory Training

Interventions

  • BehavioralOlfactory Memory Training

    Participants will complete 48 OMT sessions at home lasting approximately 10 minutes each over 3 months.

  • BehavioralVisual Memory Training

    Participants will complete 48 VMT sessions at home lasting approximately 10 minutes each over 3 months.

06

What researchers measure

Primary outcomes

  1. Change in Preclinical Alzheimer's Cognitive Composite 5 (PACC5)

    The PACC5 provides a comprehensive assessment of Alzheimer's disease-relevant cognitive impairment and to serve as a tool with validated sensitivity to detect cognitive decline over time. It is comprised of five tests: Mini-Mental State Examination (total score range 0-30), Wechsler Memory Scale-Revised Logical Memory Delayed Recall (total score range 0-25), Digit-Symbol Coding Test (total score range 0-93), Free and Cued Selective Reminding Test Free + Total Recall (total score range 0-96), and Category Fluency Test (graded by number of correct words belonging in the categories of animals, fruits, and vegetables; not graded on a scale). The PACC5 is computed as an averaged z-score of all five tests.

    Time frame: Baseline, 3 Months, 6 Months

  2. Change in Sniffin' Sticks TDI (Threshold, Discrimination, and Identification composite)

    The Sniffin' Sticks TDI test consists of a threshold test, a discrimination test, and an identification test. The results of the three subtests makes a total TDI score, where the minimum score is 1 and the maximum score is 48. A score \>30 indicates normal olfactory function, a score between 15-30 indicates hyposmia and a score \<15 indicates anosmia in the form of severely impaired or complete loss of olfaction.

    Time frame: Baseline, 3 Months, 6 Months

  3. Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL-PI)

    The range of scores of the 15 items ADL question is 0-45 with higher scores indicating better daily functioning. This is the ADCS-ADL-PI outcome measure. In addition, there is a range of scores for the 5 items of physical function questions, which is 0-5 with higher scores indicating intact physical functioning.

    Time frame: Baseline, 3 Months, 6 Months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The investigators will make de-identified data available to qualified users through a data repository.

Supporting information: Statistical analysis plan, Informed consent form

Time frame: The research community will have access to data starting 6 months after the publication of the results that address the Aims of the study.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Mar 2028, 31 months after the start.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 31 months is above that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2025
First posted
Feb 13, 2025
StartActual
Aug 7, 2025
Primary completionEst.
Mar 31, 2028
CompletionEst.
Mar 31, 2028
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06825403
Lead sponsor
Jeffrey Motter
Collaborators
Alzheimer's Association
Responsible party
Jeffrey Motter (Research Scientist, New York State Psychiatric Institute) — Sponsor-investigator
First posted
Feb 13, 2025
Start date
Aug 7, 2025
Primary completion
Mar 31, 2028 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Sep 4, 2026

Study contacts

Jeffrey N Motter, PhD
Contact
jeffrey.motter@nyspi.columbia.edu
6467748654
Jeffrey N Motter, PhD
principal investigator · Research Foundation for Mental Hygiene, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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