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

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ClinicalTrials.gov Identifier: NCT02849639
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Daniela Moga, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Other: Placebo Other: Medication Therapy Management (MTM) Drug: Scopolamine patch Early Phase 1

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE Study
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Placebo Comparator: Placebo

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.

Other: Placebo
Participants will receive educational materials, but will not receive MTM.
Other Name: Control

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.
Other Name: Scopolamine Challenge

Active Comparator: Medication Therapy Management (MTM)

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.

Other: Medication Therapy Management (MTM)
Participants will receive MTM in addition to the educational materials.
Other Name: Intervention

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.
Other Name: Scopolamine Challenge




Primary Outcome Measures :
  1. Medication Appropriateness Index scale [ Time Frame: change from baseline to end of study, an average of 1 year ]
    change from baseline to end of study

  2. Cognitive Reserve: Trail Making Test B with and without the scopolamine patch [ Time Frame: change from baseline to end of study, an average of 1 year ]
    change from baseline to end of study for Trail Making Test B


Secondary Outcome Measures :
  1. Cognitive Reserve: Montreal Cognitive Assessment [ Time Frame: change from baseline to end of study, an average of 1 year ]
    change from baseline to end of study for Montreal Cognitive Assessment

  2. Cognitive Reserve: California Verbal Learning test [ Time Frame: change from baseline to end of study, an average of 1 year ]
    change from baseline to end of study for California Verbal Learning test

  3. Perceived Health Status [ Time Frame: change from baseline to end of study, an average of 1 year ]
    change from baseline to end of study for Short Form Health Survey (SF-36)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 101 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849639


Contacts
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Contact: Shani Bardach, PhD 859-323-1331 shbardach@uky.edu
Contact: Daniela Moga, MD, PhD (859) 323-9682 Daniela.moga@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Brooke Beech    859-323-4547    brooke.beech@uky.edu   
Sponsors and Collaborators
Daniela Moga
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Daniela Moga, MD, PhD University of Kentucky

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Responsible Party: Daniela Moga, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT02849639     History of Changes
Other Study ID Numbers: 16-0375-F2L INCREASE
1R01AG054130-01 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniela Moga, University of Kentucky:
deprescribing
medication therapy management
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics