Clinical trial NCT05122598: Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease
Official title: Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Early Alzheimer's Disease
Memory Impairment
Keywords: Cognition
Memory
Alzheimer's Disease
Computerized Olfactory Training Device
Lead sponsor: Evon Medics LLC
Sponsor class: INDUSTRY
Collaborators: name: Howard University
name: Family and Medical Counseling Service, Inc
name: Medical Home Development Group
name: National Institute on Aging (NIA)
name: Johns Hopkins University
First posted: 2021-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Age 55-95 years; female must be post-menopausal for ≥ 2 consecutive years
2. Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines
3. MMSE score between the range of 21 to 27; CDR score of 1.0 (mild AD); scores on Logical Memory II subscale (Delayed Recall) from the Wechsler Memory Scale-Revised (WMS) within the recommended education-adjusted ranges
4. Have either cerebrospinal fluid (CSF) Aβ42 levels that are consistent with Alzheimer's disease as measured via mass spectrometry by C2N, or document elevated amyloid burden consistent with Alzheimer's disease from positron emission tomography (PET) imaging
5. Screening MRI without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease.
6. All participants must have a study partner with normal cognitive function.

Exclusion Criteria:

1. Any significant neurologic disease
2. Major psychiatric disorder within the past 2 years
3. Substance use disorder within the past 2 years
4. Any unstable medical condition
5. Contraindications to MRI
6. Any Alzheimer's disease modifying therapy (DMT) in the past 6 months
7. Antipsychotics, anticholinergics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications and blood thinners, except for aspirin at a prophylactic dose or less.

Primary outcomes:
measure: Logical Memory II subscale (Delayed Paragraph Recall)
timeFrame: Baseline
measure: Logical Memory II subscale (Delayed Paragraph Recall)
timeFrame: 6 months
measure: Logical Memory II subscale (Delayed Paragraph Recall)
timeFrame: 9 months
measure: ADCS-PACC composite score
timeFrame: Baseline
measure: ADCS-PACC composite score
timeFrame: 6 months
measure: ADCS-PACC composite score
timeFrame: 9 months
measure: Olfactory Psychophysical Tasks scores
timeFrame: Baseline
measure: Olfactory Psychophysical Tasks scores
timeFrame: 6 months
measure: Olfactory Psychophysical Tasks scores
timeFrame: 9 months
measure: Changes in cortical thickness and grey matter volumes
timeFrame: Baseline and 9 months
measure: Changes in subfield segmentations of the hippocampus and entorhinal cortex
timeFrame: Baseline and 9 months
Secondary outcomes:
measure: Changes in the scores of Neuropsychological Test Battery (NTB)
timeFrame: Baseline, 6 months and 9 months
measure: Changes in the scores of Mini Mental State Examination (MMSE)
timeFrame: Baseline, 6 months and 9 months
measure: Changes in the scores of CDR scale (CDR)
timeFrame: Baseline, 6 months and 9 months
measure: Changes in the scores of Global Deterioration Scale(GDS)
timeFrame: Baseline, 6 months and 9 months
measure: Changes in the scores of Activities of Daily Living (ADCS-ADL)
timeFrame: Baseline, 6 months and 9 months
measure: Changes in the scores of Quality of Life scale (QOL)
timeFrame: Baseline, 6 months and 9 months
measure: Changes in odor discrimination scores
timeFrame: Baseline, 9 months
measure: Changes in the grey matter volumes of other structures of the primary olfactory cortex
timeFrame: Baseline, 9 months
measure: Changes in the cortical thickness of other structures of the primary olfactory cortex
timeFrame: Baseline, 9 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Clinics of Dr. Edwin Chapman @ MHDG
state: District of Columbia
city: Washington
country: United States
facility: Family and Medical Counseling Service, Inc
state: District of Columbia
city: Washington
country: United States
facility: Howard University (HU)
state: District of Columbia
Study officials:
affiliation: Evon Medics LLC
name: Evaristus Nwulia, MD
role: PRINCIPAL_INVESTIGATOR
References: