The INCREASE Study - Delaying the Onset of Alzheimer's Symptomatic Expression
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 65 - 101 |
| Updated: | 3/30/2019 |
| Start Date: | April 4, 2017 |
| End Date: | March 2021 |
| Contact: | Shani Bardach, PhD |
| Email: | shbardach@uky.edu |
| Phone: | 859-323-1331 |
INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE Study
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.
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.
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).
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).
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
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