NCT02849639

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

INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Daniela Moga · Academic / Other
• Sex: All
• Age: 65 Years – 101 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Alzheimer's Disease
• Dementia

Interventions

Type	Name	Description
OTHER	Placebo	Participants will receive educational materials, but will not receive MTM.
OTHER	Medication Therapy Management (MTM)	Participants will receive MTM in addition to the educational materials.
DRUG	Scopolamine patch	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.

Timeline

• Start date: 2017-04-04
• Primary completion: 2021-04-21
• Completion: 2021-04-21
• First posted: 2016-07-29
• Last updated: 2023-07-19
• Results posted: 2022-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study