Mild Cognitive ImpairmentPhase 2NCT05122598
Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease
A Phase 2 study testing COT in people with Mild Cognitive Impairment and Early Alzheimer's Disease, run by Evon Medics LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Mild Cognitive Impairment, Early Alzheimer's Disease, Memory Impairment
- What is being tested?
- COT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Nov 2021to 30 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55-95 years; female must be post-menopausal for ≥ 2 consecutive years
- Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines
- 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
- 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
- Screening MRI without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease.
- All participants must have a study partner with normal cognitive function.
Who cannot join
- Any significant neurologic disease
- Major psychiatric disorder within the past 2 years
- Substance use disorder within the past 2 years
- Any unstable medical condition
- Contraindications to MRI
- Any Alzheimer's disease modifying therapy (DMT) in the past 6 months
- Antipsychotics, anticholinergics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications and blood thinners, except for aspirin at a prophylactic dose or less.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Clinics of Dr. Edwin Chapman @ MHDG
Washington D.C., District of Columbia, 20002
Edwin Chapman, MD, 202-396-8550, echap1647@aol.com
- Recruiting
Family and Medical Counseling Service, Inc
Washington D.C., District of Columbia, 20020
Michael Serlin, MD, 202-889-7900 ext. 573, mserlin@fmcsinc.org]
- Recruiting
Howard University (HU)
Washington D.C., District of Columbia, 20060
Thomas O Obisesan, MD, 202-865-6100, tobisesan@howard.edu
About this study
Official title: Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
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.
Read the 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.
- Being tested
- COT, Sham
- Keywords
- Cognition, Memory, Alzheimer's Disease, Computerized Olfactory Training Device
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COTDrug
Also called COT with olfactory stimulants
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.
ShamDrug
Also called Sham COT
Sham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Olfactory Training (COT) Device with olfactory stimulants | Active comparator | 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. Receives: Drug: COT |
| Sham/COT Device | Sham comparator | 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. Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logical Memory II subscale (Delayed Paragraph Recall)
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
Measured: Baseline
Logical Memory II subscale (Delayed Paragraph Recall)
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
Measured: 6 months
Logical Memory II subscale (Delayed Paragraph Recall)
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
Measured: 9 months
ADCS-PACC composite score
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Measured: Baseline
ADCS-PACC composite score
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Measured: 6 months
ADCS-PACC composite score
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Measured: 9 months
Olfactory Psychophysical Tasks scores
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); Threshold Discrimination Identification (TDI) composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
Measured: Baseline
Olfactory Psychophysical Tasks scores
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); TDI composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
Measured: 6 months
Olfactory Psychophysical Tasks scores
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); TDI composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
Measured: 9 months
Changes in cortical thickness and grey matter volumes
Defines as MRI imaging changes of the hippocampus and entorhinal cortex
Measured: Baseline and 9 months
Changes in subfield segmentations of the hippocampus and entorhinal cortex
Using the Automatic Segmentation of Hippocampal subfields looking for changes in the hippocampus and entorhinal cortex
Measured: Baseline and 9 months
Secondary outcomes (9)
Changes in the scores of Neuropsychological Test Battery (NTB)
Neuropsychological Test Battery (NTB) is a combination of widely used clinical neuropsychological tests measuring memory and executive function. he total Neuropsychological Test Battery (NTB) executive function is a composite score obtained from averaging the following three z-scores from the NTB: Wechsler Memory Scale Digit Span, Controlled Word Association Test (COWAT), and Category Fluency Test (CFT). The range in z scores is from -3 to 3; higher scores indicating less executive function deficit.
Measured: Baseline, 6 months and 9 months
Changes in the scores of Mini Mental State Examination (MMSE)
Mini Mental State Examination (MMSE) measures cognitive function and includes tests of orientation, attention, memory, language and visual-spatial skills. MMSE range 0 - 30; higher scores indicating less deficit.
Measured: Baseline, 6 months and 9 months
Changes in the scores of CDR scale (CDR)
Clinical Dementia Rating Scale (CDR) is a 5- point scale used to characterize six domains of cognitive and functional performance (Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care) applicable to Alzheimer's disease and related dementias.
CDR Score is the sum of boxes scores range from 0 - 18; higher scores indicating worse deficit.
Measured: Baseline, 6 months and 9 months
Changes in the scores of Global Deterioration Scale(GDS)
GDS provides an overview of the stages of cognitive function for those suffering from primary degenerative dementia such as Alzheimer's disease. Geriatric Depression Scale (GDS) scores range from 0 - 30; higher scores indicating worse depression.
Measured: Baseline, 6 months and 9 months
Changes in the scores of Activities of Daily Living (ADCS-ADL)
ADCS-ADL is used for assessment of patient's ability to perform activities of daily living. ADCS-ADL is a 23-item activities of daily with score range from 0 - 78; lower scores indicating greater impairment.
Measured: Baseline, 6 months and 9 months
Changes in the scores of Quality of Life scale (QOL)
QOL measures satisfaction, perceptions of control, involvement, commitment and work-life balance, in terms of one's personal perception. QOL-AD score ranges from 13 - 52; higher scores indicating less deficit.
Measured: Baseline, 6 months and 9 months
Changes in odor discrimination scores
Odor discrimination score defines patient's ability to detect differences between odors.
Measured: Baseline, 9 months
Changes in the grey matter volumes of other structures of the primary olfactory cortex
Primary olfactory region images will use MPRAGE MRI sequence for grey matter volume
Measured: Baseline, 9 months
Changes in the cortical thickness of other structures of the primary olfactory cortex
Primary olfactory region images will use MPRAGE MRI sequence for cortical thickness
Measured: Baseline, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start15 Nov 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evon Medics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Howard University, Family and Medical Counseling Service, Inc, Medical Home Development Group, National Institute on Aging (NIA), Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Evaristus Nwulia, MD, Principal investigator, Evon Medics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122598
- Sponsor's protocol ID
- COTAG061981
- Other IDs
- 2R44AG061981-03
- Status last verified
- May 2022
- First submitted
- 28 Sep 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT05122598
- Acronym / sponsor ID
- COTAG061981
- Keywords
- Cognition, Memory, Alzheimer's Disease, Computerized Olfactory Training Device
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Evon Medics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Howard University, Family and Medical Counseling Service, Inc, Medical Home Development Group, National Institute on Aging (NIA), Johns Hopkins University
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Olfactory Training (COT) Device with olfactory stimulants | Active comparator | Drug: COTCOT 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/COT Device | Sham comparator | Drug: ShamThis 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. |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 55-95 years; female must be post-menopausal for ≥ 2 consecutive years
- Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines
- 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
- 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
- Screening MRI without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease.
Key exclusion criteria (7 listed)
- Any significant neurologic disease
- Major psychiatric disorder within the past 2 years
- Substance use disorder within the past 2 years
- Any unstable medical condition
- Contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COTAlso: COT with olfactory stimulantsThe 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. | Drug | Computerized Olfactory Training (COT) Device with olfactory stimulants |
| ShamAlso: Sham COTSham COT uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks. | Drug | Sham/COT Device |
Primary outcome
Logical Memory II subscale (Delayed Paragraph Recall)
Time frame: Baseline
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
Logical Memory II subscale (Delayed Paragraph Recall)
Time frame: 6 months
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
Logical Memory II subscale (Delayed Paragraph Recall)
Time frame: 9 months
Measures patient's ability to recall information after a 20 to 30 minutes delay for story b from the Wechsler Memory Scale-IV (0-25). Higher scores indicate better performance. This is use for evaluation of forgetting or memory decay.
ADCS-PACC composite score
Time frame: Baseline
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
ADCS-PACC composite score
Time frame: 6 months
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
ADCS-PACC composite score
Time frame: 9 months
Combines tests that assess episodic memory, timed executive function and global cognition. Alzheimer's Disease Cooperative Study (ADCS) PACC (ADAS-PACC) is a composite score of: The Total Recall score from the Free and Cued Selective Reminding Test (FCSRT) (range from 0-48 points), The Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (range from 0-25 points), the Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (range from 0-93 points), and the MMSE score (range from 0-30 points). Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Olfactory Psychophysical Tasks scores
Time frame: Baseline
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); Threshold Discrimination Identification (TDI) composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
Olfactory Psychophysical Tasks scores
Time frame: 6 months
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); TDI composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
Olfactory Psychophysical Tasks scores
Time frame: 9 months
Using Sniffin' sticks, defines patient's olfactory threshold (T), discrimination (D) and identification (I). Scores: Male and Female threshold score (1-16); Male and Female discrimination score (4-16); Identification score (male: 3-16; female: 4-16); TDI composite score (male: 9-44; female: 11-43). Higher score indicates better olfactory performance.
Changes in cortical thickness and grey matter volumes
Time frame: Baseline and 9 months
Defines as MRI imaging changes of the hippocampus and entorhinal cortex
Changes in subfield segmentations of the hippocampus and entorhinal cortex
Time frame: Baseline and 9 months
Using the Automatic Segmentation of Hippocampal subfields looking for changes in the hippocampus and entorhinal cortex
9 secondary outcomes
Changes in the scores of Neuropsychological Test Battery (NTB)
Time frame: Baseline, 6 months and 9 months
Changes in the scores of Mini Mental State Examination (MMSE)
Time frame: Baseline, 6 months and 9 months
Changes in the scores of CDR scale (CDR)
Time frame: Baseline, 6 months and 9 months
Changes in the scores of Global Deterioration Scale(GDS)
Time frame: Baseline, 6 months and 9 months
Changes in the scores of Activities of Daily Living (ADCS-ADL)
Time frame: Baseline, 6 months and 9 months
Changes in the scores of Quality of Life scale (QOL)
Time frame: Baseline, 6 months and 9 months
Changes in odor discrimination scores
Time frame: Baseline, 9 months
Changes in the grey matter volumes of other structures of the primary olfactory cortex
Time frame: Baseline, 9 months
Changes in the cortical thickness of other structures of the primary olfactory cortex
Time frame: Baseline, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evaristus Nwulia, MD principal investigator
Evon Medics LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COT in people with Mild Cognitive Impairment and Early Alzheimer's Disease, run by Evon Medics LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evaristus Nwulia, MD (410-227-2005, enwulia@evonmedics.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Logical Memory II subscale (Delayed Paragraph Recall) (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.