Vascular DementiaPhase 1NCT03702543
Managing Vascular Dementia Risk Factors With SymTrend
A Phase 1 study testing SymTrend, Inc. in people with Vascular Dementia, run by SymTrend Inc. at 1 site in United States.
Trial summary
Individuals with uncontrolled vascular disease are at risk for an insidious progression of brain injury starting in early to midlife and ultimately culminating in a vascular dementia, robbing them of activities of daily living independence. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Vascular Dementia
- What is being tested?
- SymTrend, Inc.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 14 Oct 2019
- Phase
- Phase 1
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior incidence of neurological event such as transient ischemic attack, stroke.
Who cannot join
- Inability to use smartphone,
- Inability to read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurology Department, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Individuals with uncontrolled vascular disease are at risk for an insidious progression of brain injury starting in early to midlife and ultimately culminating in a vascular dementia, robbing them of activities of daily living independence. Successful containment of this progression requires rigorous vascular risk factor management - the control of blood pressure, blood sugars, weight, and alcohol consumption; the cessation of smoking, and an increase in aerobic activity. SymTrend's mobile and web system for managing vascular risk factors will help improve adherence to health and lifestyle strategies, will stem cognitive decline, and will preserve independence in the community for older adults.
Read the detailed description
Neurologists from Massachusetts General Hospital will refer 10 adults with vascular mild cognitive impairment for participation in this project. The patients will be given Bluetooth devices appropriate for their condition and will be trained to use SymTrend and Apple Health software. They will use the software and devices for three months; will receive messages throughout from the system and/or a research coordinator about their progress, with encouragement and strategies to fully manage their symptoms; and their neurologist will be in communication with them about the progress charts and will adjust their care on the basis of this real-time data.
- Conditions
- Vascular Dementia
- Being tested
- SymTrend, Inc.
- Medical subject headings
- Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymTrend, Inc.Behavioural
Use of SymTrend and Apple Health apps with feedback and strategies provided.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved management of blood sugar
Blood sugars are measured regularly and are maintained within bounds prescribed by MD
Measured: three months
Improved blood pressure management
Blood pressure is measured regularly and is within bounds prescribed by MD
Measured: three months
Reduced smoking
Number of cigarettes smoked is reduced or eliminated
Measured: three months
Weight is reduced if necessary
Food intake is reduced and is healthier, and as a consequence weight is reduced
Measured: three months
Activity level is increased
Step count increases continuously throughout study period
Measured: three months
Secondary outcomes (1)
Fatigue is reduced if originally is a problem
Hours sleep increases and frequency of sleep interruption reduces
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start15 Oct 2018 (estimated)
- Primary completion14 Oct 2019 (estimated)
- Study completion14 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DementiaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this feasibility study, a customized electronic diary will be provided to collect data 1) from bluetooth devices, 2) from Apple Health app information, and 3) from self-reported diary information. Researchers will provide feedback via charts and reminders/text messages to encourage management of vascular risk factors.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SymTrend Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Minna Levine, Phd, Principal investigator, SymTrend Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702543
- Sponsor's protocol ID
- 1R43AG060851-01
- Other IDs
- 1R43AG060851-01
- Status last verified
- Oct 2018
- First submitted
- 5 Oct 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Vascular Dementia Risk Factors With SymTrend
- ClinicalTrials.gov ID
- NCT03702543
- Acronym / sponsor ID
- 1R43AG060851-01
- Conditions
- Vascular Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- SymTrend Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Massachusetts General Hospital
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 14 Oct 2019 (estimated)
- Study completion
- 14 Oct 2019 (estimated)
- First posted
- 11 Oct 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.
Individuals with uncontrolled vascular disease are at risk for an insidious progression of brain injury starting in early to midlife and ultimately culminating in a vascular dementia, robbing them of activities of daily living independence. Successful containment of this progression requires rigorous vascular risk factor management - the control of blood pressure, blood sugars, weight, and alcohol consumption; the cessation of smoking, and an increase in aerobic activity. SymTrend's mobile and web system for managing vascular risk factors will help improve adherence to health and lifestyle strategies, will stem cognitive decline, and will preserve independence in the community for older adults.
Detailed description
Neurologists from Massachusetts General Hospital will refer 10 adults with vascular mild cognitive impairment for participation in this project. The patients will be given Bluetooth devices appropriate for their condition and will be trained to use SymTrend and Apple Health software. They will use the software and devices for three months; will receive messages throughout from the system and/or a research coordinator about their progress, with encouragement and strategies to fully manage their symptoms; and their neurologist will be in communication with them about the progress charts and will adjust their care on the basis of this real-time data.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- In this feasibility study, a customized electronic diary will be provided to collect data 1) from bluetooth devices, 2) from Apple Health app information, and 3) from self-reported diary information. Researchers will provide feedback via charts and reminders/text messages to encourage management of vascular risk factors.
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prior incidence of neurological event such as transient ischemic attack, stroke.
Key exclusion criteria (2 listed)
- Inability to use smartphone,
- Inability to read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SymTrend, Inc.Use of SymTrend and Apple Health apps with feedback and strategies provided. | Behavioural | – |
Primary outcome
Improved management of blood sugar
Time frame: three months
Blood sugars are measured regularly and are maintained within bounds prescribed by MD
Improved blood pressure management
Time frame: three months
Blood pressure is measured regularly and is within bounds prescribed by MD
Reduced smoking
Time frame: three months
Number of cigarettes smoked is reduced or eliminated
Weight is reduced if necessary
Time frame: three months
Food intake is reduced and is healthier, and as a consequence weight is reduced
Activity level is increased
Time frame: three months
Step count increases continuously throughout study period
1 secondary outcome
Fatigue is reduced if originally is a problem
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Minna Levine, Phd principal investigator
SymTrend Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SymTrend, Inc. in people with Vascular Dementia, run by SymTrend Inc. 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minna Levine, Phd (16174917510, symtrend@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved management of blood sugar (time frame: three months). The study lists 5 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 11 Oct 2018.