Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease
Mild Cognitive Impairment, Early Alzheimer's Disease, Memory Impairment
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Cognition, Memory, Alzheimer's Disease, Computerized Olfactory Training Device
Eligibility Criteria
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.
- 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.
Sites / Locations
- Clinics of Dr. Edwin Chapman @ MHDGRecruiting
- Family and Medical Counseling Service, IncRecruiting
- Howard University (HU)Recruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Computerized Olfactory Training (COT) Device with olfactory stimulants
Sham/COT Device
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.
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.