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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG054130-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Medication Therapy Management (MTM) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Participants will receive educational materials, but will not receive MTM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Appropriateness Index | 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. | change from baseline to end of study, an average of 1 year |
| Trail Making Test B With the Scopolamine Patch | 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. | baseline to end of study, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Reserve: Montreal Cognitive Assessment | Change from baseline to end of study for Montreal Cognitive Assessment. Z score is based on the NACC cognitively normal population (https://files.alz.washington.edu/documentation/weintraub-2018-v3.pdf), Z score = 0 corresponds mean MoCA score for cognitively normal older adults; higher Z scores are better; typical neuropsych interpretation of z scores is that -1.5 indicates impaired performance on that test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Moga, MD, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31888732 | Result | 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. | |
| 36281668 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Placebo: Participants will receive educational materials, but will not receive MTM. 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. |
| FG001 | 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. Medication Therapy Management (MTM): Participants will receive MTM in addition to the educational materials. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Placebo: Participants will receive educational materials, but will not receive MTM. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication Appropriateness Index | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | change from baseline to end of study, an average of 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Placebo: Participants will receive educational materials, but will not receive MTM. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injurious fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurological | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniela C Moga MD PhD, Associate Professor | University of Kentucky | 859-323-9682 | daniela.moga@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2018 | Jul 5, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2015 | Jul 27, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2019 | Nov 8, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| D008722 | Methods |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
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| Medication Therapy Management (MTM) | Other | Participants will receive MTM in addition to the educational materials. |
|
|
| Scopolamine patch | Drug | 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. |
|
|
| change from baseline to end of study, an average of 1 year |
| Cognitive Reserve: California Verbal Learning Test | Change from baseline to end of study for California Verbal Learning test. Z scores (higher scores are better; Z score = 0 corresponds mean CVLT score for cognitively normal older adults; typical neuropsych interpretation of z scores is that -1.5 indicates impaired performance on that test) are adjusted for age and sex and are based on the normative population used to develop norms for CVLT-II; "individuals sampled to create the normative data were tested cross-sectionally, demographically matched to the most recent U.S. Censuses, and screened for self-reported neurological, psychiatric, or debilitating medical illnesses." Delis, D. C., Kramer, J. H., Kaplan, E., & Ober, B. A. (1987-2000). California Verbal Learning Test--Second Edition (CVLT -II) [Database record]. APA PsycTests. | change from baseline to end of study, an average of 1 year |
| Perceived Health Status | Change from baseline to end of study for Short Form Health Survey (SF-36). T scores have a mean of 50 and SD of 10; higher scores are better; mean = 50 represents expected mean in general US adult population, with no available clinically relevant thresholds . | change from baseline to end of study, an average of 1 year |
| 36894900 | Derived | Smith NI, Martinez AI, Huffmyer M, Eckmann L, George R, Abner EL, Jicha GA, Moga DC. Acceptability of patient-centered, multi-disciplinary medication therapy management recommendations: results from the INCREASE randomized study. BMC Geriatr. 2023 Mar 10;23(1):137. doi: 10.1186/s12877-023-03876-4. |
| BG001 | 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. Medication Therapy Management (MTM): Participants will receive MTM in addition to the educational materials. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Standardized Uptake Value ratio | Quantitative SUVR determinations based on Aβ-PET imaging allow for the specification of amyloid burden as a continuous variable. We used predefined cut-off points at 1.2 and 1.4 to categorize amyloid burden. Values grater than 1.4 in the absence of cognitive impairment indicate a preclinical Alzheimer's Disease state. | Count of Participants | Participants |
|
| Years of education | Mean | Standard Deviation | years |
|
| Total number of medications | Mean | Standard Deviation | medications |
|
| Number of medications on 2015 Beers list | Beers criteria list medications that are considered potentially inappropriate for adults 65 years and older. The list is updated on a regular basis through expert panel review under the American Geriatrics Society. | Mean | Standard Deviation | medications |
|
| Medication appropriateness index | The 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. Medication Therapy Management (MTM): Participants will receive MTM in addition to the educational materials. 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. |
|
|
| Primary | Trail Making Test B With the Scopolamine Patch | 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. | Posted | Least Squares Mean | Standard Error | z-scores | baseline to end of study, an average of 1 year |
|
|
|
| Secondary | Cognitive Reserve: Montreal Cognitive Assessment | Change from baseline to end of study for Montreal Cognitive Assessment. Z score is based on the NACC cognitively normal population (https://files.alz.washington.edu/documentation/weintraub-2018-v3.pdf), Z score = 0 corresponds mean MoCA score for cognitively normal older adults; higher Z scores are better; typical neuropsych interpretation of z scores is that -1.5 indicates impaired performance on that test. | MoCA (Z score, NACC UDS norms), challenged condition | Posted | Least Squares Mean | Standard Error | z-score | change from baseline to end of study, an average of 1 year |
|
|
|
| Secondary | Cognitive Reserve: California Verbal Learning Test | Change from baseline to end of study for California Verbal Learning test. Z scores (higher scores are better; Z score = 0 corresponds mean CVLT score for cognitively normal older adults; typical neuropsych interpretation of z scores is that -1.5 indicates impaired performance on that test) are adjusted for age and sex and are based on the normative population used to develop norms for CVLT-II; "individuals sampled to create the normative data were tested cross-sectionally, demographically matched to the most recent U.S. Censuses, and screened for self-reported neurological, psychiatric, or debilitating medical illnesses." Delis, D. C., Kramer, J. H., Kaplan, E., & Ober, B. A. (1987-2000). California Verbal Learning Test--Second Edition (CVLT -II) [Database record]. APA PsycTests. | CVLT Long Delay (Z score), challenged condition | Posted | Least Squares Mean | Standard Error | z-score | change from baseline to end of study, an average of 1 year |
|
|
|
| Secondary | Perceived Health Status | Change from baseline to end of study for Short Form Health Survey (SF-36). T scores have a mean of 50 and SD of 10; higher scores are better; mean = 50 represents expected mean in general US adult population, with no available clinically relevant thresholds . | SF-36 Mental Component Score (T score), challenged condition | Posted | Least Squares Mean | Standard Error | t-score | change from baseline to end of study, an average of 1 year |
|
|
|
| 2 |
| 44 |
| 9 |
| 44 |
| 42 |
| 44 |
| EG001 | 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. Medication Therapy Management (MTM): Participants will receive MTM in addition to the educational materials. 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. | 0 | 46 | 7 | 46 | 41 | 46 |
| Infections | Infections and infestations | Non-systematic Assessment |
|
| Major cardiac event | Cardiac disorders | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| GI emergencies | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Surgical complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Car accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| GI | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infections | Infections and infestations | Non-systematic Assessment |
|
| Allergies | Immune system disorders | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
|
| Renal and GU | Renal and urinary disorders | Non-systematic Assessment |
|
| Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
| Metabolic | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Visual | Eye disorders | Non-systematic Assessment |
|
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Auditory | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D008919 | Investigative Techniques |