The INCREASE Study - Delaying the Onset of Alzheimer's Symptomatic Expression

• Status: Completed
• Trial end date: 2021-04-21
• Target enrollment: 0
• Participant gender: All

Summary

The study will examine the impact on cognitive reserve of a pharmacist-physician patient-centered medication therapy management intervention to address inappropriate medication use as identified by the Beers 2015 list. By bolstering cognitive reserve, this project will directly address the National Alzheimer's Project Act 2015 priorities serving to delay onset of symptoms in preclinical dementia. The results of this study will provide valuable insights on how to expand this intervention to reduce the prevalence and associated healthcare costs of symptomatic Alzheimer's disease.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniela Moga
• Collaborator: National Institute on Aging (NIA)
• Treatments: Butylscopolammonium Bromide; Scopolamine; Scopolamine Hydrobromide

Criteria

Inclusion Criteria:

• Non-demented

• No previous reaction or contraindication to scopolamine patch, or medical condition warranting dose adjustment in scopolamine including but not limited to: open angle glaucoma, gastrointestinal or urinary outlet obstructions, seizures, or psychosis.

• No contraindications to Aβ-PET scan including hypersensitivity to PET ligand or radiation exposures in the past year that would exceed the acceptable safe annual exposure in combination with the Aβ PET

• Medically stable and able to complete all study activities, as determined by the investigator

• Reporting at least one potentially inappropriate medication as listed in the Beers 2015 criteria

• Living in the community

• Willing to participate in this intervention study

Exclusion Criteria:

• Allergy or other know intolerance to scopolamine patches

• Narrow-angle glaucoma

• Difficulty swallowing

• Stomach or bowel problems (e.g., blockage, muscle weakness, ulcerative colitis)

• Bleeding

• Acid reflux disease

• Myasthenia gravis

• Blockage of the urinary tract.

• Seizures

• Psychosis