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| ID | Type | Description | Link |
|---|---|---|---|
| AARG-24-1301387 | Other Grant/Funding Number | Alzheimer's Association |
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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olfactory Memory Training | Active Comparator |
| |
| Visual Memory Training | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olfactory Memory Training | Behavioral | Participants will complete 48 OMT sessions at home lasting approximately 10 minutes each over 3 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 Months, 6 Months |
| 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. | Baseline, 3 Months, 6 Months |
| 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. | Baseline, 3 Months, 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey N Motter, PhD | Contact | 6467748654 | jeffrey.motter@nyspi.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey N Motter, PhD | Research Foundation for Mental Hygiene, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | Recruiting | New York | New York | 10032 | United States |
The investigators will make de-identified data available to qualified users through a data repository.
The research community will have access to data starting 6 months after the publication of the results that address the Aims of the study.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000086582 | Anosmia |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000857 | Olfaction Disorders |
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Participants will be randomized 1:1 to either Olfactory Memory Training (OMT) or Visual Memory Training (VMT) by random number generators.
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Due to the pilot nature of the study and fundamental differences between OMT and VMT, neither the participants nor research personnel will be blinded to treatment assignment.
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| Visual Memory Training | Behavioral | Participants will complete 48 VMT sessions at home lasting approximately 10 minutes each over 3 months. |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019954 | Neurobehavioral Manifestations |