Recruiting
Phase 2

COT

Sponsor:

Evon Medics LLC

Code:

NCT05122598

Conditions

Mild Cognitive Impairment

Early Alzheimer's Disease

Memory Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

COT

Sham

Study Details

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.

Conditions

Mild Cognitive Impairment

Early Alzheimer's Disease

Memory Impairment

Study ID

NCT05122598

Start date

Nov 15, 2021

Status verified date

May, 2022

Completion date

Apr 30, 2023

Anticipated

Primary completion date

Apr 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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.

sham comparator: 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.

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.

Sham

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

Primary outcome measure

  • Logical Memory II subscale (Delayed Paragraph Recall) [ Time Frame: Baseline ]
  • Logical Memory II subscale (Delayed Paragraph Recall) [ Time Frame: 6 months ]
  • Logical Memory II subscale (Delayed Paragraph Recall) [ Time Frame: 9 months ]
  • ADCS-PACC composite score [ Time Frame: Baseline ]
  • ADCS-PACC composite score [ Time Frame: 6 months ]
  • ADCS-PACC composite score [ Time Frame: 9 months ]
  • Olfactory Psychophysical Tasks scores [ Time Frame: Baseline ]
  • Olfactory Psychophysical Tasks scores [ Time Frame: 6 months ]
  • Olfactory Psychophysical Tasks scores [ Time Frame: 9 months ]
  • Changes in cortical thickness and grey matter volumes [ Time Frame: Baseline and 9 months ]
  • Changes in subfield segmentations of the hippocampus and entorhinal cortex [ Time Frame: Baseline and 9 months ]

Central Contacts and Locations

Central contacts

Evaristus Nwulia, MD

410-227-2005enwulia@evonmedics.org

Maria Hipolito, MD

571-241-2766mhipolito@evonmedics.org

Locations

Clinics of Dr. Edwin Chapman @ MHDG

Recruiting

Washington, District of Columbia, United States, 20002

Contacts

Edwin Chapman, MD

202-396-8550echap1647@aol.com

Family and Medical Counseling Service, Inc

Recruiting

Washington, District of Columbia, United States, 20020

Contacts

Michael Serlin, MD

202-889-7900mserlin@fmcsinc.org]

Howard University (HU)

Recruiting

Washington, District of Columbia, United States, 20060

Contacts

Thomas O Obisesan, MD

202-865-6100tobisesan@howard.edu

More Information

Sponsor

Evon Medics LLC

Last update posted

May 17, 2022

Last verified

May, 2022

Keywords

  • Cognition
  • Memory
  • Alzheimer's Disease
  • Computerized Olfactory Training Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Evon Medics LLC on 2022-05-17.