Computerized Olfactory Training (COT) Device with olfactory stimulants for Alzheimer's Disease

Clinics of Dr. Edwin Chapman @ MHDG, Washington, United States
Alzheimer's Disease+2 More ConditionsCOT - Drug
Eligibility
55 - 95
All Sexes
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Study Summary

This trial will test whether a new treatment approach, called COT, can help people with memory loss.

Eligible Conditions
  • Alzheimer's Disease
  • Memory Loss
  • Mild Cognitive Impairment

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

5 Primary · 9 Secondary · Reporting Duration: Baseline, 6 months and 9 months

9 months
ADCS-PACC composite score
Logical Memory II subscale (Delayed Paragraph Recall)
Olfactory Psychophysical Tasks scores
Baseline and 9 months
Changes in cortical thickness and grey matter volumes
Changes in subfield segmentations of the hippocampus and entorhinal cortex
Month 9
Changes in the scores of Activities of Daily Living (ADCS-ADL)
Changes in the scores of CDR scale (CDR)
Changes in the scores of Global Deterioration Scale(GDS)
Changes in the scores of Mini Mental State Examination (MMSE)
Changes in the scores of Neuropsychological Test Battery (NTB)
Changes in the scores of Quality of Life scale (QOL)
Baseline, 9 months
Changes in odor discrimination scores
Olfactory Cortex
Changes in the grey matter volumes of other structures of the primary olfactory cortex

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Computerized Olfactory Training (COT) Device with olfactory stimulants
1 of 2
Sham/COT Device
1 of 2

Active Control

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Computerized Olfactory Training (COT) Device with olfactory stimulants · Has Placebo Group · Phase 2

Computerized Olfactory Training (COT) Device with olfactory stimulants
Drug
ActiveComparator Group · 1 Intervention: COT · Intervention Types: Drug
Sham/COT Device
Drug
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 months and 9 months

Who is running the clinical trial?

Evon Medics LLCLead Sponsor
1 Previous Clinical Trials
190 Total Patients Enrolled
Howard UniversityOTHER
36 Previous Clinical Trials
12,938 Total Patients Enrolled
Family and Medical Counseling Service, IncUNKNOWN
1 Previous Clinical Trials
190 Total Patients Enrolled
Medical Home Development GroupUNKNOWN
1 Previous Clinical Trials
140 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,487 Previous Clinical Trials
5,129,107 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,115 Previous Clinical Trials
32,578,570 Total Patients Enrolled
Evaristus Nwulia, MDPrincipal InvestigatorEvon Medics LLC

Eligibility Criteria

Age 55 - 95 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are experiencing early signs of Alzheimer's disease, as defined by the National Institute on Aging/Alzheimer's Association guidelines.

Frequently Asked Questions

What are the fundamental goals of this scientific investigation?

"The primary goal of this clinical trial, which is due to run for approximately 9 months, will be determined by the ADCS-PACC composite score. Additionally, secondary objectives include shifts in patients' Activities of Daily Living (ADCS-ADL) scores assessed on a 23-item scale ranging from 0 -78; lower scores reflecting higher impairment., modifications to grey matter volumes within the Primary Olfactory Cortex as visualised via MPRAGE MRI scans, and changes to Quality Of Life (QOL) ratings with values between 13 and 52; increased numbers indicating better quality of life outcomes." - Anonymous Online Contributor

Unverified Answer

How many participants are partaking in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical research was made public on November 15th 2021 and has recently been revised on May 12th 2022. 200 participants are being sought from 3 different trial sites." - Anonymous Online Contributor

Unverified Answer

Has the FDA certified a Computerized Olfactory Training Device that utilizes olfactory stimulants?

"Our assessment of the safety of this Computerized Olfactory Training (COT) Device with olfactory stimulants is a 2 as there has only been preliminary evidence presented to support its security. No clinical data yet exists that speaks to efficacy." - Anonymous Online Contributor

Unverified Answer

Is there an age limit for potential participants of this research?

"The requirements to join this clinical trial specify that patients must be aged between 55 and 95 years old. Meanwhile, the study has 44 trials for minors and 939 studies available for those above 65 years of age." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts ongoing for this trial?

"This clinical trial is recruiting, with the initial posting dated November 15th 2021 and a recent update of May 12th 2022. This information can be found on the website for clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

Do I meet the requirements to partake in this experiment?

"Heeding the requirements of this medical trial, 200 volunteers who are between 55 and 95 years old with memory issues can be enrolled." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.