HealthyNCT02265718
A Study To Evaluate The Difference In iPad-Based Cognitive Video Game (Akili Interactive's Project: EVO) Performance In Amyloid-Positive Versus Amyloid-Negative Healthy Elderly Volunteers
An observational study of Healthy, run by Pfizer at 4 sites in United States.
Trial summary
The purpose of the study is to evaluate the difference in learning and performance measures associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in healthy elderly volunteers based on amyloid status. Read more about this study
- Who is it for?
- Ages 70 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ritalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2014to May 2016
- 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 70 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy males and females between the ages of 70 and 80.
- Subjects must have BMI of 17.5 to 32 kg/m2 and total body weight > 110 pounds.
- Acceptable screening MRI and PET scans that pass quality control requirements.
Who cannot join
- Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
- MMSE (mini mental state examination) score <26
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Broward Research Group
Hollywood, Florida, 33024
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Miami Research Associates
South Miami, Florida, 33143
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Trial To Study Difference In Cognitive Learning Associated With Repeated Self-administration Of Remote Computer Tablet-based Application Assessing Dual-task Performance Based On Amyloid Status In Healthy Elderly Volunteers
The purpose of the study is to evaluate the difference in learning and performance measures associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in healthy elderly volunteers based on amyloid status.
- Conditions
- Healthy
- Being tested
- Ritalin, Placebo
- Keywords
- Healthy, elderly volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitalinDrug
Also called methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28
1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
PlaceboDrug
Also called matched placebo tablet taken once on day 0 and once on day 28
1 - matching tablet taken once on Day 0 and once on Day 28
RitalinDrug
Also called methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 28
1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
PlaceboDrug
Also called matched placebo tablet taken once on day 0 and once on day 28
1 - matching tablet taken once on Day 0 and once on Day 28
| Study group | Role | What they receive |
|---|---|---|
| (Amyloid Negative) | Not described Receives: Drug: Ritalin; Drug: Placebo | |
| Amyloid Positive | Not described Receives: Drug: Ritalin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
divided attention performance
The difference in effect of cognitive training on divided attention performance as measured by teh pre/post training change in interference cost on EVO dueal task assessment at Day 28.
Measured: Day 0 - Day 28
Secondary outcomes (3)
sustained attention, impulsivity and episodic memory
The difference in effect of cognitive training on sustained attention, impulsivity and episodic memory as measured by the pre/post training change in performance at day 28
Measured: Day 0 - Day 28
perforamce on EVO dual task assessment, TOVA and RAVLT
The performance on EVO dual task assessment, Test of Variables of Attention (TOVA and Rey Auditory Verbal Learning Test (RAVLT) as measured by the pre and post training scores at Day 0 and Day 28
Measured: Day 0 - Day 28
within subject change on EVO, TOVA and RAVLT
The within subject change on EVO dual task assessment, TOVA and RAVLT between day -28 and Day 0.
Measured: Day 0 - Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265718
- Sponsor's protocol ID
- A9001489
- Status last verified
- Jun 2019
- First submitted
- 13 Oct 2014
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Trial To Study Difference In Cognitive Learning Associated With Repeated Self-administration Of Remote Computer Tablet-based Application Assessing Dual-task Performance Based On Amyloid Status In Healthy Elderly Volunteers
- ClinicalTrials.gov ID
- NCT02265718
- Acronym / sponsor ID
- A9001489
- Conditions
- Healthy
- Keywords
- Healthy, elderly volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Oct 2014 (estimated)
- 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.
The purpose of the study is to evaluate the difference in learning and performance measures associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in healthy elderly volunteers based on amyloid status.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Amyloid Negative) | – | Drug: Ritalin, Drug: Placebo |
| Amyloid Positive | – | Drug: Ritalin, Drug: Placebo |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy males and females between the ages of 70 and 80.
- Subjects must have BMI of 17.5 to 32 kg/m2 and total body weight > 110 pounds.
- Acceptable screening MRI and PET scans that pass quality control requirements.
Key exclusion criteria (2 listed)
- Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
- MMSE (mini mental state examination) score <26
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 |
|---|---|---|
| RitalinAlso: methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 281 - 20 mg tablet taken once on Day 0 and taken once on Day 28 | Drug | (Amyloid Negative) |
| PlaceboAlso: matched placebo tablet taken once on day 0 and once on day 281 - matching tablet taken once on Day 0 and once on Day 28 | Drug | (Amyloid Negative) |
| RitalinAlso: methylphenidate hydrochloride 20mg tablet taken once on day 0 and once on day 281 - 20 mg tablet taken once on Day 0 and taken once on Day 28 | Drug | Amyloid Positive |
| PlaceboAlso: matched placebo tablet taken once on day 0 and once on day 281 - matching tablet taken once on Day 0 and once on Day 28 | Drug | Amyloid Positive |
Primary outcome
divided attention performance
Time frame: Day 0 - Day 28
The difference in effect of cognitive training on divided attention performance as measured by teh pre/post training change in interference cost on EVO dueal task assessment at Day 28.
3 secondary outcomes
sustained attention, impulsivity and episodic memory
Time frame: Day 0 - Day 28
perforamce on EVO dual task assessment, TOVA and RAVLT
Time frame: Day 0 - Day 28
within subject change on EVO, TOVA and RAVLT
Time frame: Day 0 - Day 28
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 5 Jun 2019.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Pfizer at 4 sites 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 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: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
divided attention performance (time frame: Day 0 - Day 28). 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 5 Jun 2019.