The INCREASE Study - Delaying the Onset of Alzheimer's Symptomatic Expression
Condition: Alzheimer's Disease; Dementia
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      This is a 12-month, parallel arm, study to be conducted at the University of Kentucky. The
      study will involve assessing medication use and identifying any medicines that may be
      inappropriate for elderly adults.

      At the beginning of the study, participants will be asked to undergo one amyloid-PET scan to
      detect early amyloid plaques in their brain which could increase the risk of Alzheimer's
      disease in the near future. In addition, at the beginning and end of the study, participants
      will be asked to use a scopolamine patch. This patch is not being used to prevent motion
      sickness (as approved by the FDA), but instead is being used to challenge the participant's
      memory and thinking abilities.

      Part of the study includes collecting information regarding participants memory and thinking
      abilities. Participants will be asked to complete questionnaires as well as memory and
      thinking tests.

      A study doctor will review participants medical history and then perform routine medical
      (physical and neurological) examinations.

      Two of the study visits will be conducted by phone to check up on the participants.

      At the beginning, middle, and end of the study, participants will meet with a doctor and
      pharmacist to review and make any changes deemed appropriate to their current medicines. This
      will be done in order to try and eliminate medicines that are not recommended for the
      elderly. These visits are referred to as the Medication Therapy Management (MTM).
    

Intervention name(s): Placebo; Medication Therapy Management (MTM); Scopolamine patch
Intervention type(s): Other; Other; Drug
Intervention description(s): Participants will receive educational materials, but will not receive MTM.; Participants will receive MTM in addition to the educational materials.; At the beginning and end of the study, participants will be asked to use a scopolamine patch. This patch is not being used to prevent motion sickness (as approved by the FDA), but instead is being used to challenge the participant's memory and thinking abilities and determine cognitive reserve.
Other intervention name(s): Control; Intervention; Scopolamine Challenge
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: deprescribing; medication therapy management