Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Ea… (NCT05122598) | Clinical Trial Compass
UnknownPhase 2
Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease
United States200 participantsStarted 2021-11-15
Plain-language 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.
Who can participate
Age range
55 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Logical Memory II subscale (Delayed Paragraph Recall)
Timeframe: Baseline
2
Logical Memory II subscale (Delayed Paragraph Recall)
Timeframe: 6 months
3
Logical Memory II subscale (Delayed Paragraph Recall)
. All participants must have a study partner with normal cognitive function.
Exclusion criteria
. 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.
9
Olfactory Psychophysical Tasks scores
Timeframe: 9 months
10
Changes in cortical thickness and grey matter volumes
Timeframe: Baseline and 9 months
11
Changes in subfield segmentations of the hippocampus and entorhinal cortex