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Behavioural Intervention

Computerized Olfactory Training (COT) Device with olfactory stimulants for Mild Cognitive Impairment

Phase 2
Recruiting
Led By Evaristus Nwulia, MD
Research Sponsored by Evon Medics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months and 9 months
Awards & highlights

Study Summary

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

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are experiencing early signs of Alzheimer's disease, as defined by the National Institute on Aging/Alzheimer's Association guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months and 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADCS-PACC composite score
Changes in cortical thickness and grey matter volumes
Changes in subfield segmentations of the hippocampus and entorhinal cortex
+2 more
Secondary outcome measures
Changes in odor discrimination scores
Olfactory Cortex
Changes in the grey matter volumes of other structures of the primary olfactory cortex
+6 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Computerized Olfactory Training (COT) Device with olfactory stimulantsActive Control1 Intervention
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 II: Sham/COT DevicePlacebo Group1 Intervention
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.

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Who is running the clinical trial?

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
1,653 Previous Clinical Trials
28,004,775 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~60 spots leftby Mar 2025