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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG063909 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to a usual care control. Participants will be randomized to attend 40 min remotely delivered group moderate to vigorous physical activity (MVPA) sessions at low frequency (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control usual care control (UC). In addition to the group MVPA sessions, participants in both the RL and RH groups will also receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. Content for both the RL and RH arms will be identical with the exception of group session frequency (1 vs. 3/wk.). Participants in the UC arm will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education).The primary aim is to Assess daily MVPA (min) in the RL, RH, and UC arms at baseline, 3, 6, 9, and 12 mos., and obtain effect sizes for change in MVPA over 12-mos.Secondary Aim 1 is to assess the impact of MVPA on cardiovascular fitness, quality of life, cognitive function, and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, and cerebral blood flow) at baseline, 6, and 12 mos. Secondary Aim 2 will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) of RL, RH, and UC interventions.
This research study will compare 3 strategies for the delivery of an intervention to increase moderate to vigorous physical activity (MVPA) in community dwelling adults with Down Syndrome; remotely delivered group MVPA sessions at low (1 session/wk.,RL), high frequency (3 sessions/wk., RH), or usual care control (UC). Adults (age ≥ 18 yrs.) with Down Syndrome will be randomized (2:2:1) to one of the 3 intervention arms for an 12-mo. trial. Cohorts of ~20 adults with Down Syndrome will be recruited and computer randomized. Participants will be stratified by sex and sequentially randomized by the study statistician. Participants in all arms will be provided with an iPad for intervention delivery, Fitbit for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Participants in the RL and RH arms will be asked to complete 40 minutes MVPA sessions delivered via Zoom software on an iPad, RL will be provided 1 session/wk, and RH will be provided 3 sessions/wk. Participants in both the RL and RH groups will also receive one 20-min remotely delivered individual support/education session/wk. with a heath coach to discuss progress and provide support. The UC intervention will follow the traditional approach to promote increased MVPA. Participants will receive an iPad tablet loaded with information regarding increasing MVPA and will also receive resistance bands and a Fitbit for self-monitoring MVPA. Monthly 20-min. education/support sessions, identical to the education/support sessions provided in the RL and RH arms, will be delivered to participants and their caregivers remotely on the iPad using FaceTime. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, daily MVPA (min) in the RL, RH, and UC arms will be assessed at baseline, 3, 6, 9, and 12 mos. using an accelerometer. All secondary outcomes will be assessed at baselines, 6, and 12 months. Secondary outcomes are to assess the impact of MVPA across the RL, RH, and UC arms on cardiovascular fitness, quality of life, cognitive function and brain parameters related to Alzheimer's Disease (whole and regional brain volume, functional connectivity, cerebral blood flow). Additionally the researchers will determine the feasibility (retention, session attendance, use of recorded sessions (RH/RL only) and safety of RL, RH, and UC arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Low | Other |
| |
| Remote High | Other |
| |
| Personal Coach | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Low | Behavioral | Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | MVPA was assessed using an ActiGraph tri-axial accelerometer. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function | Working memory, processing speed, multitasking, and episodic memory will be assessed at baseline, 6 and, and 12 months, using tests selected from the widely used Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, LTD, Cambridge, UK) for Down syndrome. The CANTAB for Down syndrome uses a battery of tests including multitasking, episodic memory, executive function and processing speed. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight will be measured in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg. | Baseline to 12 months |
| Height | Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Ptomey, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40520478 | Derived | Ptomey LT, Helsel BC, Washburn RA, Montgomery RN, Krebill R, Danon JC, Sherman JR, Forsha D, Bodde A, Szabo-Reed AN, Gorczyca AM, Donnelly JE. The promotion of physical activity for use in Alzheimer's disease prevention trials in adults with Down syndrome: Results from a 12-month randomized trial. Alzheimers Dement (N Y). 2025 Jun 12;11(2):e70115. doi: 10.1002/trc2.70115. eCollection 2025 Apr-Jun. | |
| 38057709 | Derived | Frank L, Helsel B, Dodd D, Bodde AE, Danon JC, Sherman JR, Forsha DE, Szabo-Reed A, Washburn RA, Donnelly JE, Ptomey LT. The association between cardiovascular health and cognition in adults with Down syndrome. J Neurodev Disord. 2023 Dec 6;15(1):43. doi: 10.1186/s11689-023-09510-z. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remote High | Remote High: Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. |
| FG001 | Remote Low | Remote Low: Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. |
| FG002 | Personal Coach | Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remote High | Remote High: Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. |
| BG001 | Remote Low |
| 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 | Minutes of Moderate to Vigorous Physical Activity (MVPA) Per Day | MVPA was assessed using an ActiGraph tri-axial accelerometer. | Only participants who had valid accelerometer wear time (8 hrs a day for at least 3 weekdays/1weekend day) are included at each timepoint. | Posted | Mean | Standard Deviation | min of MVPA/day | Baseline to 12 months |
|
1 year
Events collected during outcome assessment appointments, before each exercise session, and during monthly health education meetings.
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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 | Remote High | Remote High: Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystectomy | Gastrointestinal disorders | Systematic Assessment | Emergent gall bladder removal |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lauren Ptomey | University of Kansas Medical Center | 913-588-7983 | lptomey@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2022 | Jun 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Remote High | Behavioral | Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. |
|
| Personal Coach | Behavioral | Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. |
|
| Baseline to 12 months |
| Cardiovascular Fitness | Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months | Baseline to 12 months |
| Change in Quality of Life | Quality of life will be assessed at baseline, 6, and 12 months with the Personal Well-Being Index Intellectual Disability, which contains 7 items, each corresponding to a quality of life domain: standard of living, health, life achievement, personal relationships, personal safety, community connectedness, and future security. Participants answer questions on a 0-4 scale, with 0 being least happy and 4 being most happy. | Baseline to 12 months |
| Brain Volume | Brain volume will be measured using structural MRI at baseline, 6, and 12 months | Baseline to 12 months |
| Functional Connectivity | Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months. | Baseline to 12 months |
| Cerebral Blood Flow | Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months | Baseline to 12 months |
| Retention | Retention will be measured by the percentage of participants who complete the 12 month intervention, defined as completing the 12 month outcome assessments. | Baseline to 12 months |
| Session Attendance | Session attendance for both group MVPA and education/support sessions from baseline to 12 months will be obtained from records maintained by the health educator, and expressed as the percent of possible sessions. Attendance at group MVPA sessions will be defined as being logged in to the video conference and remaining on the screen for the entire 30-min session. Attendance at individual support/education sessions, for the both exercise and UC conditions, will be defined as answering the FaceTime call, and being present on screen for the entire session. | Baseline to 12 months |
| Use of Recorded Exercise Sessions | Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video. | Baseline to 12 months |
| Reported Serious Adverse Event | Safety will be measured by number of participants reporting a serious adverse event, i.e., any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or results in persistent or significant disability/incapacity. | Baseline to 12 months |
| Baseline to 12 months |
| Waist Circumference | Waist circumference will be assessed using a waist tape measure. | Baseline to 12 months |
| Energy Expenditure of Exercise Sessions | The energy expenditure of sessions will be collected by a portable metabolic system at random timepoints across the 12 month study. | Baseline to 12 months |
| Functional Lower Extremity Strength | Functional lower extremity strength will be assessed using the Five Times Sit to Stand | Baseline to 12 months |
| Functional Mobility | Functional mobility will be assessed using the Timed Up and Go. | Baseline to 12 months |
| Upper Body Strength | Upper body strength will be assessed using hand grip dynamometer | Baseline to 12 months |
| Activities of Daily Living | Activities of daily living will be assessed using the Waisman Activities of Daily Living scale. This scale contains 17 questions, each item is rated as 0="does not do", 1="does with help", or 2="does independently / on own. A higher score indicates greater independence. | Baseline to 12 months |
| Caregiver Burden | Caregiver burden will be assess using The Modified Caregiver Strain Index. The tool has 13 questions that measure strain related to care provision. Scoring is 2 points for each 'yes', 1 point for each 'sometimes', and 0 for each 'no' response. Scoring ranges from 26 to 0; a higher score indicates a higher level of caregiver strain. | Baseline to 12 months |
| Caregiver Stress | Caregiver stress will be assessed by the Caregiver Self-Assessment Questionnaire. This questionnaire is 18 questions, 16 with yes or no responses, and 2 ranking questions. Typically a higher score indicates a higher level of caregiver stress. | Baseline to 12 months |
| Caregiver Quality of Life | Caregiver quality of life will be assessed by the Adult Carer Quality of Life Questionnaire. The Adult Carer Quality of Life Questionnaire is a 40-item instrument that measures the overall quality of life for adult carers. Scores on the have a possible range of 0 to 120 with higher scores indicating greater quality of life. | Baseline to 12 months |
| 37407386 | Derived | Dodd D, Helsel B, Bodde AE, Danon JC, Sherman JR, Donnelly JE, Washburn RA, Ptomey LT. The association of increased body mass index on cardiorespiratory fitness, physical activity, and cognition in adults with down syndrome. Disabil Health J. 2023 Oct;16(4):101497. doi: 10.1016/j.dhjo.2023.101497. Epub 2023 Jun 16. |
| 32642594 | Derived | Ptomey LT, Szabo-Reed AN, Martin LE, Mayo MS, Washburn RA, Gorczyca AM, Lepping RJ, Lee P, Forsha DE, Sherman JR, Danon JC, Donnelly JE. The promotion of physical activity for the prevention of Alzheimer's disease in adults with Down Syndrome: Rationale and design for a 12 Month randomized trial. Contemp Clin Trials Commun. 2020 Jun 30;19:100607. doi: 10.1016/j.conctc.2020.100607. eCollection 2020 Sep. |
Remote Low: Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. |
| BG002 | Personal Coach | Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. |
| BG003 | 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 |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Personal Coach | Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. |
|
|
| Secondary | Cognitive Function | Working memory, processing speed, multitasking, and episodic memory will be assessed at baseline, 6 and, and 12 months, using tests selected from the widely used Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, LTD, Cambridge, UK) for Down syndrome. The CANTAB for Down syndrome uses a battery of tests including multitasking, episodic memory, executive function and processing speed. | Not Posted | Baseline to 12 months | Participants |
| Secondary | Cardiovascular Fitness | Maximal treadmill tests (modified Balke protocol) will be completed at baseline, 6, and 12 months | Not Posted | Baseline to 12 months | Participants |
| Secondary | Change in Quality of Life | Quality of life will be assessed at baseline, 6, and 12 months with the Personal Well-Being Index Intellectual Disability, which contains 7 items, each corresponding to a quality of life domain: standard of living, health, life achievement, personal relationships, personal safety, community connectedness, and future security. Participants answer questions on a 0-4 scale, with 0 being least happy and 4 being most happy. | Not Posted | Baseline to 12 months | Participants |
| Secondary | Brain Volume | Brain volume will be measured using structural MRI at baseline, 6, and 12 months | Not Posted | Baseline to 12 months | Participants |
| Secondary | Functional Connectivity | Functional connectivity will be measured using resting state MRI (rsMRI) at baseline, 6, and 12 months. | Not Posted | Baseline to 12 months | Participants |
| Secondary | Cerebral Blood Flow | Functional connectivity will be measured using arterial spin labeling at baseline, 6, and 12 months | Not Posted | Baseline to 12 months | Participants |
| Secondary | Retention | Retention will be measured by the percentage of participants who complete the 12 month intervention, defined as completing the 12 month outcome assessments. | Not Posted | Baseline to 12 months | Participants |
| Secondary | Session Attendance | Session attendance for both group MVPA and education/support sessions from baseline to 12 months will be obtained from records maintained by the health educator, and expressed as the percent of possible sessions. Attendance at group MVPA sessions will be defined as being logged in to the video conference and remaining on the screen for the entire 30-min session. Attendance at individual support/education sessions, for the both exercise and UC conditions, will be defined as answering the FaceTime call, and being present on screen for the entire session. | Not Posted | Baseline to 12 months | Participants |
| Secondary | Use of Recorded Exercise Sessions | Use of recorded exercise sessions will be tracked using Dropbox which provides information on how many times each user watched a video. | Not Posted | Baseline to 12 months | Participants |
| Secondary | Reported Serious Adverse Event | Safety will be measured by number of participants reporting a serious adverse event, i.e., any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or results in persistent or significant disability/incapacity. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Weight | Weight will be measured in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Height | Standing height will be measured with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Waist Circumference | Waist circumference will be assessed using a waist tape measure. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Energy Expenditure of Exercise Sessions | The energy expenditure of sessions will be collected by a portable metabolic system at random timepoints across the 12 month study. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Functional Lower Extremity Strength | Functional lower extremity strength will be assessed using the Five Times Sit to Stand | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Functional Mobility | Functional mobility will be assessed using the Timed Up and Go. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Upper Body Strength | Upper body strength will be assessed using hand grip dynamometer | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Activities of Daily Living | Activities of daily living will be assessed using the Waisman Activities of Daily Living scale. This scale contains 17 questions, each item is rated as 0="does not do", 1="does with help", or 2="does independently / on own. A higher score indicates greater independence. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Caregiver Burden | Caregiver burden will be assess using The Modified Caregiver Strain Index. The tool has 13 questions that measure strain related to care provision. Scoring is 2 points for each 'yes', 1 point for each 'sometimes', and 0 for each 'no' response. Scoring ranges from 26 to 0; a higher score indicates a higher level of caregiver strain. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Caregiver Stress | Caregiver stress will be assessed by the Caregiver Self-Assessment Questionnaire. This questionnaire is 18 questions, 16 with yes or no responses, and 2 ranking questions. Typically a higher score indicates a higher level of caregiver stress. | Not Posted | Baseline to 12 months | Participants |
| Other Pre-specified | Caregiver Quality of Life | Caregiver quality of life will be assessed by the Adult Carer Quality of Life Questionnaire. The Adult Carer Quality of Life Questionnaire is a 40-item instrument that measures the overall quality of life for adult carers. Scores on the have a possible range of 0 to 120 with higher scores indicating greater quality of life. | Not Posted | Baseline to 12 months | Participants |
| 0 |
| 34 |
| 2 |
| 34 |
| 7 |
| 34 |
| EG001 | Remote Low | Remote Low: Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk. | 0 | 32 | 3 | 32 | 1 | 32 |
| EG002 | Personal Coach | Personal Coach: Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education. | 0 | 15 | 1 | 15 | 4 | 15 |
|
| Mitral Valve Regurgitation | Cardiac disorders | Systematic Assessment | Transespophageal echocardiogram revealed severe mitral valve regurgitation related to congenital heart disease |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospital admittance due to pulmonary edema cause by congestive heart failure |
|
| Appendectomy | Immune system disorders | Systematic Assessment | Emergent appendectomy due to ruptured appendix |
|
| Spinal infection | Infections and infestations | Systematic Assessment | Surgery to mitigate effects of spinal infection. |
|
| Isthmic Spondylolisthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Surgery to mitigate the effects of previous isthmus spondylolisthesis. |
|
| COVID-19 Infection | Infections and infestations | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gastritis and gastroparesis | Gastrointestinal disorders | Systematic Assessment |
|
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| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |