Development and Evaluation of Computerized Olfactory Training Program for Cognitive Decline in Early Alzheimer's Disease

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Evon Medics LLC
• Collaborators: Clinics of Dr. Edwin Chapman, MD, PC @ MHDG; Family and Medical Counseling Service, Inc; Howard University; National Institute on Aging (NIA)
• Treatments: Central Nervous System Stimulants

Criteria

Inclusion Criteria:

1. Age 65-85 years; female must be post-menopausal for ≥ 2 consecutive years

2. Probable mild AD according to the core clinical criteria outlined in the National Institute on Aging/Alzheimer's Association (NIA-AA) Guidelines

3. 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

4. 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

5. Screening MRI without evidence of infection, infarction, or other focal lesions of neurological disease; and no significant nasal disease.

6. All participants must have a study partner with normal cognitive function.

Exclusion Criteria:

1. Any significant neurologic disease

2. Major psychiatric disorder within the past 2 years

3. Substance use disorder within the past 2 years

4. Any unstable medical condition

5. Contraindications to MRI

6. Any Alzheimer's disease modifying therapy (DMT) in the past 6 months

7. Antipsychotics, anticholinergics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications and blood thinners, except for aspirin at a prophylactic dose or less.