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

NCT02849639 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-07-19

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Daniela Moga

    lead OTHER

Principal Investigators

  • Daniela Moga, MD, PhD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
101 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2021-04-21
Completion
2021-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02849639 on ClinicalTrials.gov