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

NCT ID: NCT05122598

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2023-04-30

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.

Conditions

Mild Cognitive Impairment; Early Alzheimer's Disease; Memory Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Computerized Olfactory Training (COT) Device with olfactory stimulants

COT device with olfactory stimulants consists of daily 40 cycles of intervention with a combination of olfactory stimulation and training tasks, lasting \~45 minutes, delivered once daily over 6 months period by the participant or their partner/caregiver.

Group Type: ACTIVE_COMPARATOR

COT

Intervention Type: DRUG

The COT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.

Sham/COT Device

This is COT device that uses compressed room air scented with phenylethylamine (rose scent) instead of olfactory stimulants and has shape pattern matching tasks instead of cognitive tasks, in order to blind users to their treatment assignment. Similar to the COT, sham COT will be used daily for 45 minutes.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DRUG

Sham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks.

Interventions

COT

The COT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.

Intervention Type: DRUG

Sham

Sham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks.

Intervention Type: DRUG

Other Intervention Names

COT with olfactory stimulants; Sham COT

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Howard University

OTHER

Sponsor Role: collaborator

Family and Medical Counseling Service, Inc

UNKNOWN

Sponsor Role: collaborator

Medical Home Development Group

UNKNOWN

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Evon Medics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evaristus Nwulia, MD

Role: PRINCIPAL_INVESTIGATOR

Evon Medics LLC

Locations

Clinics of Dr. Edwin Chapman @ MHDG

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Family and Medical Counseling Service, Inc

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Howard University (HU)

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evaristus Nwulia, MD

Role: CONTACT

enwulia@evonmedics.org

410-227-2005

Maria Hipolito, MD

Role: CONTACT

mhipolito@evonmedics.org

571-241-2766

Facility Contacts

Edwin Chapman, MD

Role: primary

echap1647@aol.com

202-396-8550

Michael Serlin, MD

Role: primary

mserlin@fmcsinc.org]

202-889-7900 ext. 573

Thomas O Obisesan, MD

Role: primary

tobisesan@howard.edu

202-865-6100

Other Identifiers

2R44AG061981-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

COTAG061981

Identifier Type: -

Identifier Source: org_study_id