INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's Symptomatic Expression: The INCREASE Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Medication Appropriateness Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 101 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Allergy or other know intolerance to scopolamine patches
- •Narrow-angle glaucoma
- •Difficulty swallowing
- •Stomach or bowel problems (e.g., blockage, muscle weakness, ulcerative colitis)
- •Acid reflux disease
- •Myasthenia gravis
- •Blockage of the urinary tract.
- •Psychosis
研究组 & 干预措施
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.
干预措施: Placebo (Other)
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.
干预措施: Scopolamine patch (Drug)
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.
干预措施: Medication Therapy Management (MTM) (Other)
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.
干预措施: Scopolamine patch (Drug)
结局指标
主要结局
Medication Appropriateness Index
时间窗: change from baseline to end of study, an average of 1 year
Change from baseline to end of study. The Medication Appropriateness Index (MAI) rates medications as "appropriate", "marginally appropriate", or "inappropriate" based on ten criteria. All medications reported by study participants were evaluated by the study team and assigned a medication-specific MAI. As an outcome measure, the total MAI was obtained by adding the medication specific MAIs for all medications reported by the participant. Minimum score for one medication is 0 (appropriate) and the maximum is 18 (inappropriate for all criteria). Total MAI depends on the number of medications taken by participant. A decrease in MAI from baseline to end of study indicates improvement in medication appropriateness.
Trail Making Test B With the Scopolamine Patch
时间窗: baseline to end of study, an average of 1 year
End of study for Trail Making Test B with the scopolamine patch. The mean and standard used to compute the TMTB z-scores were taken from a sample of cognitively intact older adult research volunteers (Weintraub et al. 2009; mean = 90.3, SD = 50) (22). Z-scores were then multiplied by -1 to facilitate interpretation, since higher TMTB scores are worse. For the z-score, we converted time in seconds to units of standard deviations from a mean of 0, where 0 represents the mean performance of cognitively intact (normal) older adult research volunteers enrolled in longitudinal studies at Alzheimer's Disease Research Centers in the United States. Scores that are at least 1.5 standard deviations below the mean are indicative of potential cognitive impairment.
次要结局
- Cognitive Reserve: California Verbal Learning Test(change from baseline to end of study, an average of 1 year)
- Cognitive Reserve: Montreal Cognitive Assessment(change from baseline to end of study, an average of 1 year)
- Perceived Health Status(change from baseline to end of study, an average of 1 year)
研究者
Daniela Moga
Sponsor/PI
University of Kentucky