Alzheimer Disease, Early OnsetiPACES™NCT03069391
The Interactive Physical and Cognitive Exercise System
A study testing physical exercise alone (PES) first, cognitive exercise alone (iCE) first and interactive Physical and Cognitive Exercise (iPACES™) in people with Alzheimer Disease, Early Onset and MCI, run by Union College, New York at 1 site in United States.
Trial summary
This study is intended to clarify the benefits to brain health and thinking processes that result from different forms of exercise. In particular, this study will investigate the possible benefits of physical exercise (such as pedaling an under-table stationary elliptical) or mental exercise (such as playing a… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset, MCI, Aging
- What is being tested?
- physical exercise alone (PES) first, cognitive exercise alone (iCE) first and interactive Physical and Cognitive Exercise (iPACES™)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2017to 30 Jun 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- co-residing older adults (e.g., spouses, partners, roommates, relatives)
- both at least 50 years of age
- normative/typical cognitive function or those with Mild Cognitive Impairment (MCI) or mild Neurocognitive Disorder (mNCD) or early Alzheimer's disease
- adequate vision and dexterity for on-screen assessments
- able to pedal an under-table elliptical
- permission of primary care provider and cardiologist (if applicable)
Who cannot join
- history of seizure
- Parkinson's disease
- significant dementia/memory loss
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Aging & Neuropsychology Lab @ Union College
Schenectady, New York, 12308
About this study
Official title: The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment
This study is intended to clarify the benefits to brain health and thinking processes that result from different forms of exercise. In particular, this study will investigate the possible benefits of physical exercise (such as pedaling an under-table stationary elliptical) or mental exercise (such as playing a videogame on a portable tablet), or combining these activities together (as in the iPACES™ exergame).
- Conditions
- Alzheimer Disease, Early Onset, MCI, Aging, Mild Cognitive Impairment, Neurocognitive Disorder, Cognitive Impairment
- Being tested
- physical exercise alone (PES) first, cognitive exercise alone (iCE) first, interactive Physical and Cognitive Exercise (iPACES™)
- Keywords
- exercise, exergame
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neurocognitive Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exercise alone (PES) firstBehavioural
Also called PES
following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week physical exercise-only intervention, then 2-week cognitive exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
cognitive exercise alone (iCE) firstDevice
Also called iCE
following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
interactive Physical and Cognitive Exercise (iPACES™)Device
Also called iPACES™
following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
| Study group | Role | What they receive |
|---|---|---|
| physical, cognitive, then interactive | Active comparator | physical exercise alone (PES) first, then iPACES Receives: Behavioral: physical exercise alone (PES) first; Device: interactive Physical and Cognitive Exercise (iPACES™) |
| cognitive, physical, then interactive | Active comparator | cognitive exercise alone (iCE) first, then iPACES Receives: Device: cognitive exercise alone (iCE) first; Device: interactive Physical and Cognitive Exercise (iPACES™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
executive function composite score
comprised of scores from Stroop, Trails, and Flanker
Measured: change over time from baseline to 3 months
Secondary outcomes (2)
brain-derived neurotrophic factor (BDNF)
change in amount in saliva sample over time (pg/ml) per ELISA
Measured: change over time from baseline to 3 months
Sit-Stand Test
scored performance on time and technique to move from sitting on floor to standing
Measured: change over time in score from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start4 Mar 2017
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease, Early OnsetStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union College, New York
- Sponsor type
- University, hospital or other
- Collaborators
- 1st Playable Productions, Albany Medical College, Skidmore College, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Cay Anderson-Hanley, PhD, Union College, New York
- Investigators
- Cay Anderson-Hanley, PhD, Principal investigator, Union College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069391
- Sponsor's protocol ID
- 16028
- Other IDs
- 1R41AG053120-01
- Acronym
- iPACES™
- Status last verified
- Mar 2020
- First submitted
- 7 Feb 2017
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wall K, Stark J, Schillaci A, Saulnier ET, McLaren E, Striegnitz K, Cohen BD, Arciero PJ, Kramer AF, Anderson-Hanley C. The Enhanced Interactive Physical and Cognitive Exercise System (iPACESTM v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro-Exergame for Mild Cognitive Impairment (MCI). J Clin Med. 2018 Aug 30;7(9):249. doi: 10.3390/jcm7090249.
PubMed 30200183Anderson-Hanley C, Stark J, Wall KM, VanBrakle M, Michel M, Maloney M, Barcelos N, Striegnitz K, Cohen BD, Kramer AF. The interactive Physical and Cognitive Exercise System (iPACES): effects of a 3-month in-home pilot clinical trial for mild cognitive impairment and caregivers. Clin Interv Aging. 2018 Sep 4;13:1565-1577. doi: 10.2147/CIA.S160756. eCollection 2018.
PubMed 30233154
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03069391
- Acronym / sponsor ID
- iPACES™ / 16028
- Conditions
- Alzheimer Disease, Early Onset, MCI, Aging, Mild Cognitive Impairment, Neurocognitive Disorder, Cognitive Impairment
- Keywords
- exercise, exergame
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Union College, New YorkUniversity, hospital or other
- Collaborators
- 1st Playable Productions, Albany Medical College, Skidmore College, University of Illinois at Urbana-Champaign, National Institute on Aging (NIA)
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 3 Mar 2017 (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 study is intended to clarify the benefits to brain health and thinking processes that result from different forms of exercise. In particular, this study will investigate the possible benefits of physical exercise (such as pedaling an under-table stationary elliptical) or mental exercise (such as playing a videogame on a portable tablet), or combining these activities together (as in the iPACES™ exergame).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
| Arm | Type | Receives |
|---|---|---|
| physical, cognitive, then interactive | Active comparator | Behavioral: physical exercise alone (PES) first, Device: interactive Physical and Cognitive Exercise (iPACES™)physical exercise alone (PES) first, then iPACES |
| cognitive, physical, then interactive | Active comparator | Device: cognitive exercise alone (iCE) first, Device: interactive Physical and Cognitive Exercise (iPACES™)cognitive exercise alone (iCE) first, then iPACES |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- co-residing older adults (e.g., spouses, partners, roommates, relatives)
- both at least 50 years of age
- normative/typical cognitive function or those with Mild Cognitive Impairment (MCI) or mild Neurocognitive Disorder (mNCD) or early Alzheimer's disease
- adequate vision and dexterity for on-screen assessments
- able to pedal an under-table elliptical
Key exclusion criteria (3 listed)
- history of seizure
- Parkinson's disease
- significant dementia/memory loss
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 |
|---|---|---|
| physical exercise alone (PES) firstAlso: PESfollowing 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week physical exercise-only intervention, then 2-week cognitive exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise) | Behavioural | physical, cognitive, then interactive |
| cognitive exercise alone (iCE) firstAlso: iCEfollowing 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise) | Device | cognitive, physical, then interactive |
| interactive Physical and Cognitive Exercise (iPACES™)Also: iPACES™following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise) | Device | cognitive, physical, then interactive, physical, cognitive, then interactive |
Primary outcome
executive function composite score
Time frame: change over time from baseline to 3 months
comprised of scores from Stroop, Trails, and Flanker
2 secondary outcomes
brain-derived neurotrophic factor (BDNF)
Time frame: change over time from baseline to 3 months
Sit-Stand Test
Time frame: change over time in score from baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Results publication: PubMed 30200183Wall K, Stark J, Schillaci A, Saulnier ET, McLaren E, Striegnitz K, Cohen BD, Arciero PJ, Kramer AF, Anderson-Hanley C. The Enhanced Interactive Physical and Cognitive Exercise System (iPACESTM v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro-Exergame for Mild Cognitive Impairment (MCI). J Clin Med. 2018 Aug 30;7(9):249. doi: 10.3390/jcm7090249.
- Results publication: PubMed 30233154Anderson-Hanley C, Stark J, Wall KM, VanBrakle M, Michel M, Maloney M, Barcelos N, Striegnitz K, Cohen BD, Kramer AF. The interactive Physical and Cognitive Exercise System (iPACES): effects of a 3-month in-home pilot clinical trial for mild cognitive impairment and caregivers. Clin Interv Aging. 2018 Sep 4;13:1565-1577. doi: 10.2147/CIA.S160756. eCollection 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.
Cay Anderson-Hanley, PhD principal investigator
Union College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise alone (PES) first, cognitive exercise alone (iCE) first and interactive Physical and Cognitive Exercise (iPACES™) in people with Alzheimer Disease, Early Onset and MCI, run by Union College, New York 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 6 inclusion and 3 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 31 Mar 2020. 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?
Results are not available in the source record.
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?
executive function composite score (time frame: change over time from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03069391, which also lists 2 linked publications.
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 Mar 2020.