Clinical trial NCT02849639: The INCREASE Study - Delaying the Onset of Alzheimer's Symptomatic Expression
Official title: INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alzheimer's Disease
Dementia
Keywords: deprescribing
medication therapy management
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-07-29
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 101
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility 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

Primary outcomes:
measure: Medication Appropriateness Index
timeFrame: change from baseline to end of study, an average of 1 year
measure: Trail Making Test B With the Scopolamine Patch
timeFrame: baseline to end of study, an average of 1 year
Secondary outcomes:
measure: Cognitive Reserve: Montreal Cognitive Assessment
timeFrame: change from baseline to end of study, an average of 1 year
measure: Cognitive Reserve: California Verbal Learning Test
timeFrame: change from baseline to end of study, an average of 1 year
measure: Perceived Health Status
timeFrame: change from baseline to end of study, an average of 1 year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Daniela Moga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Moga DC, Abner EL, Schmitt FA, Eckmann L, Huffmyer M, Martinez AI, Beech BF, George R, El Khouli RH, Ali D, Jicha GA. Intervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression (INCREASE) Study: Results from a Randomized Controlled Study of Medication Therapy Management Targeting a Delay in Prodromal Dementia Symptom Progression. J Prev Alzheimers Dis. 2022;9(4):646-654. doi: 10.14283/jpad.2022.55.