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

Daniela Moga

Status and phase: Completed; Early Phase 1

Conditions: Alzheimer's Disease; Dementia

Treatments: Other: Placebo; Drug: Scopolamine patch; Other: Medication Therapy Management (MTM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02849639

16-0375-F2L INCREASE

1R01AG054130-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 90 patients

Sex: All

Ages: 65 to 101 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants enrolled into this arm will only receive educational materials, but will not receive specific recommendations to make changes to the medications they are taking. Cognitive testing at the beginning and the end of the study will be done with and without a scopolamine patch to reveal cognitive reserve.

Treatment:

Drug: Scopolamine patch

Other: Placebo

Medication Therapy Management (MTM)

Active Comparator group

Description:

Participants enrolled into this arm will receive educational materials and will have their medications assessed; recommendations for changes in the medications taken will be made when appropriate. Cognitive testing at the beginning and the end of the study will be done with and without a scopolamine patch to reveal cognitive reserve.

Treatment:

Other: Medication Therapy Management (MTM)

Drug: Scopolamine patch