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NCT05122598 | UNKNOWN | Mild Cognitive Impairment

Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease
Sponsor:

Evon Medics LLC

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.

Condition or disease

Mild Cognitive Impairment

Early Alzheimer's Disease

Memory Impairment

Intervention/treatment

COT

Sham

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
Official Title : Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
Actual Study Start Date : 2021-11-15
Estimated Primary Completion Date : 2023-04-01
Estimated Study Completion Date : 2023-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years to 95 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease

Location Details

NCT05122598

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, District of Columbia

Clinics of Dr. Edwin Chapman @ MHDG

Washington, District of Columbia, United States, 20002

RECRUITING

United States, District of Columbia

Family and Medical Counseling Service, Inc

Washington, District of Columbia, United States, 20020

RECRUITING

United States, District of Columbia

Howard University (HU)

Washington, District of Columbia, United States, 20060