Alzheimer DiseaseSYNERGYNCT03430648
Is Tau Protein Linked to Mobility Function?
An observational study of Alzheimer Disease and Physical Activity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This project will provide new data to address an important question linking Alzheimer's disease neuropathology to physical disability. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Physical Activity
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 27 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Investigators plan to recruit a total of 60 people age 50 and older from the Wake Forest Alzheimer's Disease Research Center's Clinical Core group.
Who may be able to join
- 50+ years of age and participated in the Wake Forest Alzheimer's Disease Core Center study
- Willing to provide informed consent
- Not dependent on a walker
Who cannot join
- Recent cardiac event in the last 6 months
- Uncontrolled hypertension (BP >200/110 mmHg)
- Neurological (e.g., Parkinson's) or hematological disease
- Participants with a knee replacement in last 6 months
- Participants with recent eye surgery in last 6 months
- Severe musculoskeletal impairment (e.g., sciatica, fibromyalgia, severe leg/back pain)
- If willing to get an MRI, must not have indwelling metal-contraining prosthesis, pacemaker or defibrillator, history of welding, permanent make up or head/neck tattoo, or any other contraindication to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
This project will provide new data to address an important question linking Alzheimer's disease neuropathology to physical disability.
Read the detailed description
Impaired mobility is strongly linked to cognitive function and vice versa. Cognitive functions are strongly associated with mobility function, most commonly assessed using gait speed. In the Health ABC Study, Digit Symbol Substitution Test (DSST) and Modified Mini Mental Status (3MS) scores were significantly associated with gait speed and gait speed decline. Poor lower extremity performance predicts faster age-related cognitive decline and increased incidence of mild cognitive impairment (MCI) and dementia. This study will explore the role of tau protein as the neuropathologic basis for these associations.
Brain imaging markers may be the link between cognitive measures and gait. White matter disease is commonly measured by quantifying white matter (WM) lesion load, which is associated with small vessel ischemic disease. More subtle microstructural changes can be observed by calculating fractional anisotropy (FA) from diffusion tensor imaging (DTI). Aging is accompanied by changes in cortical volume, white matter microstructure and an increased prevalence of WM lesions. WM lesions have been strongly implicated in declining physical function. These brain changes are associated with impaired balance, slower movement speeds, slower chair stand times and increased falls risk.Recently, Aâ accumulation in the brain has also been linked to slow gait. This finding suggests a pathologic mechanism linking Alzheimer s disease processes to gait impairments. However, Aâ accumulation itself may not be the critical neuropathic change. In recent studies of Aâ42 and phosphorylated tau protein in cerebral spinal fluid, it has been found that low Aâ42 levels themselves are not associated with impaired cognition, but that elevated tau levels are also required. If the process of cognitive impairment parallels the process of gait impairment, it might be that tau levels are more important correlates of gait changes. To the investigators' knowledge the relationship between CSF tau levels and mobility has never been explored. PET ligands for brain tau have recently become available, but the relationship between brain tau accumulation and gait has yet to be determined. In this study, investigators will relate gait characteristics to CSF Aâ42 and phosphorylated tau levels, and perform brain PET imaging in a subset to related tau protein accumulation to gait characteristics for the first time. Both mobility impairment and Alzheimers disease (AD) occur in the context of the aging vascular system. Over the past 15 years, it has been recognized that abnormalities of thoracic aortic stiffness are associated with the development of abnormalities in small vessels supplying the brain and kidneys. As the aorta stiffens, the propagation speed of the systolic flow wave increases through the aortic lumen. (Stiffness within the thoracic aorta can be accomplished through measurement of aortic pulse wave velocity.) In hypertensive patients, aortic archway pulse wave velocity has been associated with increases in left ventricular mass as well as lacunar brain infarcts independent of age, sex, and the duration of hypertension. In the Multi-Ethnic Dallas Heart Study aortic arch pulse wave velocity is an independent predictor of white matter hyper-intensities. In those with diabetes, increasing aortic stiffness contributes to the development of small vessel microvascular dysfunction which is associated with deep white matter atrophy as well as cognitive decline. Recently, a stiffness mismatch between the thoracic aorta and small vessels within the cerebral microcirculation has been described. This mismatch impacts microvascular pulsatility and appears to diminish diffusion anisotrophy between the cerebral spinal fluid and the CNS microcirculation. This observation may contribute to retained amyloid type protein in those with AD.
- Conditions
- Alzheimer Disease, Physical Activity
- Keywords
- Tau protein, PET imaging, Alzheimer's disease
- Medical subject headings
- Alzheimer Disease, Motor Activity, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively and metabolically normal | This group has been defined as being cognitively and metabolically normal. | |
| Cognitively normal with prediabetes | This group has been defined as being cognitively normal but showing signs of prediabetes. | |
| Persons with Mild Cognitive Impairment | This group has been defined as being mildly cognitively impaired. | |
| Persons with early Alzheimer's disase | This group has been defined as having early Alzheimer's disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between CSF total and phosphorylated tau levels and gait speed
This will be done using the 400m walk test.
Measured: Baseline
Association between CSF total and phosphorylated tau levels and gait variability
This will be done using the gaitrite mat.
Measured: Baseline
Association between CSF total and phosphorylated tau levels and standing balance.
This will be done using the AMTI force plate.
Measured: Baseline
Secondary outcomes (1)
Examine the association between Digit Symbol Substitution Test and gait speed
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start7 Sep 2017
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stephen Kritchevsky, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430648
- Sponsor's protocol ID
- IRB00042050
- Other IDs
- P30AG021332
- Acronym
- SYNERGY
- Status last verified
- Aug 2023
- First submitted
- 5 Feb 2018
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Tau Protein Linked to Mobility Function?
- ClinicalTrials.gov ID
- NCT03430648
- Acronym / sponsor ID
- SYNERGY / IRB00042050
- Conditions
- Alzheimer Disease, Physical Activity
- Keywords
- Tau protein, PET imaging, Alzheimer's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will provide new data to address an important question linking Alzheimer's disease neuropathology to physical disability.
Detailed description
Impaired mobility is strongly linked to cognitive function and vice versa. Cognitive functions are strongly associated with mobility function, most commonly assessed using gait speed. In the Health ABC Study, Digit Symbol Substitution Test (DSST) and Modified Mini Mental Status (3MS) scores were significantly associated with gait speed and gait speed decline. Poor lower extremity performance predicts faster age-related cognitive decline and increased incidence of mild cognitive impairment (MCI) and dementia. This study will explore the role of tau protein as the neuropathologic basis for these associations.
Brain imaging markers may be the link between cognitive measures and gait. White matter disease is commonly measured by quantifying white matter (WM) lesion load, which is associated with small vessel ischemic disease. More subtle microstructural changes can be observed by calculating fractional anisotropy (FA) from diffusion tensor imaging (DTI). Aging is accompanied by changes in cortical volume, white matter microstructure and an increased prevalence of WM lesions. WM lesions have been strongly implicated in declining physical function. These brain changes are associated with impaired balance, slower movement speeds, slower chair stand times and increased falls risk.Recently, Aâ accumulation in the brain has also been linked to slow gait. This finding suggests a pathologic mechanism linking Alzheimer s disease processes to gait impairments. However, Aâ accumulation itself may not be the critical neuropathic change. In recent studies of Aâ42 and phosphorylated tau protein in cerebral spinal fluid, it has been found that low Aâ42 levels themselves are not associated with impaired cognition, but that elevated tau levels are also required. If the process of cognitive impairment parallels the process of gait impairment, it might be that tau levels are more important correlates of gait changes. To the investigators' knowledge the relationship between CSF tau levels and mobility has never been explored. PET ligands for brain tau have recently become available, but the relationship between brain tau accumulation and gait has yet to be determined. In this study, investigators will relate gait characteristics to CSF Aâ42 and phosphorylated tau levels, and perform brain PET imaging in a subset to related tau protein accumulation to gait characteristics for the first time. Both mobility impairment and Alzheimers disease (AD) occur in the context of the aging vascular system. Over the past 15 years, it has been recognized that abnormalities of thoracic aortic stiffness are associated with the development of abnormalities in small vessels supplying the brain and kidneys. As the aorta stiffens, the propagation speed of the systolic flow wave increases through the aortic lumen. (Stiffness within the thoracic aorta can be accomplished through measurement of aortic pulse wave velocity.) In hypertensive patients, aortic archway pulse wave velocity has been associated with increases in left ventricular mass as well as lacunar brain infarcts independent of age, sex, and the duration of hypertension. In the Multi-Ethnic Dallas Heart Study aortic arch pulse wave velocity is an independent predictor of white matter hyper-intensities. In those with diabetes, increasing aortic stiffness contributes to the development of small vessel microvascular dysfunction which is associated with deep white matter atrophy as well as cognitive decline. Recently, a stiffness mismatch between the thoracic aorta and small vessels within the cerebral microcirculation has been described. This mismatch impacts microvascular pulsatility and appears to diminish diffusion anisotrophy between the cerebral spinal fluid and the CNS microcirculation. This observation may contribute to retained amyloid type protein in those with AD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitively and metabolically normal | – | –This group has been defined as being cognitively and metabolically normal. |
| Cognitively normal with prediabetes | – | –This group has been defined as being cognitively normal but showing signs of prediabetes. |
| Persons with Mild Cognitive Impairment | – | –This group has been defined as being mildly cognitively impaired. |
| Persons with early Alzheimer's disase | – | –This group has been defined as having early Alzheimer's disease. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators plan to recruit a total of 60 people age 50 and older from the Wake Forest Alzheimer's Disease Research Center's Clinical Core group.
Key inclusion criteria (3 listed)
- 50+ years of age and participated in the Wake Forest Alzheimer's Disease Core Center study
- Willing to provide informed consent
- Not dependent on a walker
Key exclusion criteria (7 listed)
- Recent cardiac event in the last 6 months
- Uncontrolled hypertension (BP >200/110 mmHg)
- Neurological (e.g., Parkinson's) or hematological disease
- Participants with a knee replacement in last 6 months
- Participants with recent eye surgery in last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between CSF total and phosphorylated tau levels and gait speed
Time frame: Baseline
This will be done using the 400m walk test.
Association between CSF total and phosphorylated tau levels and gait variability
Time frame: Baseline
This will be done using the gaitrite mat.
Association between CSF total and phosphorylated tau levels and standing balance.
Time frame: Baseline
This will be done using the AMTI force plate.
1 secondary outcome
Examine the association between Digit Symbol Substitution Test and gait speed
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kritchevsky, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Physical Activity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between CSF total and phosphorylated tau levels and gait speed (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.