Alzheimer's DiseasePhase 1NCT00319891
Computer-Based Training for Mild Alzheimer's Disease
A Phase 1 study testing Computer-based Cognitive Training in people with Alzheimer's Disease, run by Posit Science Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effects of computer-based training program ("HiFi-AD") on the memory and cognitive abilities of individuals diagnosed with mild Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Computer-based Cognitive Training
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Oct 2006
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English.
- Mini-Mental Status Examination (MMSE) score of 22 or higher.
- Adequate visual capacity.
- Adequate hearing capacity.
- Has a caregiver with some computer experience.
- Willing and able to commit to the time requirement of the entire study.
Who cannot join
- Clinically significant cerebrovascular disease.
- Participant is planning to begin acetylcholinesterase inhibitor (AChEI) therapy.
- Participants with severe tremor.
- Axis 1 or 2 psychiatric disorders.
- History of substance abuse.
- History of head trauma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Computer-Based Training for Mild Cognitive Impairment and Mild Alzheimer's Disease
The primary objective of this study is to evaluate the effects of computer-based training program ("HiFi-AD") on the memory and cognitive abilities of individuals diagnosed with mild Alzheimer's Disease (AD).
Read the detailed description
The purpose of this study is to determine the extent to which computer-based cognitive remediation improves cognitive functions using standardized neuropsychological assessments relevant to AD; 2) the acceptability and feasibility of using computer-based cognitive remediation in an AD population.
- Conditions
- Alzheimer's Disease
- Being tested
- Computer-based Cognitive Training
- Keywords
- Alzheimer's, AD, Mild Cognitive Impairment, Dementia, Cognitive remediation, computer-based training
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based Cognitive TrainingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this trial will be to assess the feasibility of using computer-based
cognitive training in an a population with early Alzheimer's Disease.
Secondary outcomes (2)
A standardized set of neuropsychological assessments will be conducted pre- and post-
compuer-based training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startSep 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Investigators
- Joel Kramer, PsyD, Principal investigator, University of California, San FranciscoKristine Yaffe, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319891
- Sponsor's protocol ID
- OUT-109-2005
- Status last verified
- May 2013
- First submitted
- 27 Apr 2006
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Based Training for Mild Cognitive Impairment and Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00319891
- Acronym / sponsor ID
- OUT-109-2005
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's, AD, Mild Cognitive Impairment, Dementia, Cognitive remediation, computer-based training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- Sep 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006
- First posted
- 27 Apr 2006 (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 primary objective of this study is to evaluate the effects of computer-based training program ("HiFi-AD") on the memory and cognitive abilities of individuals diagnosed with mild Alzheimer's Disease (AD).
Detailed description
The purpose of this study is to determine the extent to which computer-based cognitive remediation improves cognitive functions using standardized neuropsychological assessments relevant to AD; 2) the acceptability and feasibility of using computer-based cognitive remediation in an AD population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fluent in English.
- Mini-Mental Status Examination (MMSE) score of 22 or higher.
- Adequate visual capacity.
- Adequate hearing capacity.
- Has a caregiver with some computer experience.
Key exclusion criteria (6 listed)
- Clinically significant cerebrovascular disease.
- Participant is planning to begin acetylcholinesterase inhibitor (AChEI) therapy.
- Participants with severe tremor.
- Axis 1 or 2 psychiatric disorders.
- History of substance abuse.
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 |
|---|---|---|
| Computer-based Cognitive Training | Procedure or surgery | – |
Primary outcome
The primary objective of this trial will be to assess the feasibility of using computer-based
cognitive training in an a population with early Alzheimer's Disease.
2 secondary outcomes
A standardized set of neuropsychological assessments will be conducted pre- and post-
compuer-based training.
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 15 May 2013.
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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.
Joel Kramer, PsyD principal investigator
University of California, San Francisco
Kristine Yaffe, MD principal investigator
University of California, San Francisco
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 Computer-based Cognitive Training in people with Alzheimer's Disease, run by Posit Science Corporation 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 6 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 15 May 2013. 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?
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?
The primary objective of this trial will be to assess the feasibility of using computer-based. The study lists 2 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 15 May 2013.