CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 90 enrolled
Drug / intervention
Scopolamine patch +2 moredrug
Likely dose
Scopolamine patch (dose not specified); applied at baseline and end-of-studyAI-extracted
Key inclusion· 6
  • Non-demented at baseline
  • No prior adverse reaction or contraindication to scopolamine patch
  • No contraindications to amyloid-PET scan (no hypersensitivity to PET ligand; radiation exposure in past year acceptable within safe annual limits)
  • Medically stable and able to complete all study activities per investigator
Key exclusion· 10
  • Allergy or known intolerance to scopolamine patches
  • Narrow-angle glaucoma
  • Difficulty swallowing
  • Gastrointestinal or urinary obstruction/dysfunction (blockage, muscle weakness, ulcerative colitis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02849639
NCT02849639Early Ph 1Completed

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

Daniela Moga·interventional·Posted Jul 29, 2016·Updated Jul 19, 2023

In Brief

A Early Phase 1 clinical trial evaluating Placebo, Medication Therapy Management (MTM), and 1 other intervention for Alzheimer's Disease and Dementia. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 29, 2016
Enrollment StartApr 4, 2017
Primary CompletionApr 21, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.9 years ago

Interventions

Placeboother

Participants will receive educational materials, but will not receive MTM.

Medication Therapy Management (MTM)other

Participants will receive MTM in addition to the educational materials.

Scopolamine patchdrug

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.