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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 : Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Daniela Moga, University of Kentucky

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE July 29, 2016
Last Update Posted Date May 15, 2020
Actual Study Start Date  ICMJE April 4, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The INCREASE Study - Delaying the Onset of Alzheimer's Symptomatic Expression
Official Title  ICMJE INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE Study
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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Alzheimer's Disease
  • Dementia
Intervention  ICMJE
  • Other: Placebo
    Participants will receive educational materials, but will not receive MTM.
    Other Name: Control
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Other: Placebo
    • Drug: Scopolamine patch
  • 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.

    Interventions:
    • Other: Medication Therapy Management (MTM)
    • Drug: Scopolamine patch
Publications * Moga DC, Beech BF, Abner EL, Schmitt FA, El Khouli RH, Martinez AI, Eckmann L, Huffmyer M, George R, Jicha GA. INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer's Symptomatic Expression (INCREASE), a randomized controlled trial: rationale, study design, and protocol. Trials. 2019 Dec 30;20(1):806. doi: 10.1186/s13063-019-3993-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 101 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02849639
Other Study ID Numbers  ICMJE 16-0375-F2L INCREASE
1R01AG054130-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniela Moga, University of Kentucky
Study Sponsor  ICMJE Daniela Moga
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Daniela Moga, MD, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP