Alzheimer's DiseasePhase 2LifezigNCT00759863
LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia
A Phase 2 study testing Lifezig in people with Alzheimer's Disease and Dementia, run by Photozig, Inc. at 1 site in United States.
Trial summary
The LifeZig Project is a research study of a new reminiscence activity for individuals with Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with personalized video channels containing old photographs and music on television. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Lifezig
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented diagnosis of probable Alzheimer's or other type of dementia, medically stable, and visual/hearing capabilities to watch television.
- provide care or be a family member of dementia patient, have knowledge of the person, and be able to provide old photographs of dementia patient.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Photozig, Inc.
Moffett Field, California, 94035-0128
About this study
Official title: LifeZig System for Individuals With Alzheimer's Disease
The LifeZig Project is a research study of a new reminiscence activity for individuals with Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with personalized video channels containing old photographs and music on television.
The goal of the LifeZig study is to enhance the quality of life for dementia patients and their families/caregivers, decrease the burden of care, and contribute to positive interaction between dementia patients and families/caregivers.
Read the detailed description
This program creates personalized TV channels with old photographs of AD patients, music, narration and relaxing sounds; as an activity to relax dementia patients.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Lifezig
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifezigBehavioural
Also called LifeZig Personalized Reminiscence Slideshow
Personalized Reminiscence Video
| Study group | Role | What they receive |
|---|---|---|
| Lifezig | Experimental | Subjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system) Receives: Behavioral: Lifezig |
| Usual Care | No intervention | Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Observation Scale for Elderly Subject
This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: "Personal Care", "Communication, Awareness \& Memory", "Mood", and "Interpersonal Awareness Behaviors". The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144.
Measured: 6 months
Secondary outcomes (2)
Revised Memory and Behavior Problems Checklist
This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. Best value = 0. Worst Value = 96.
Measured: 6 months
Center for Epidemiologic Studies Depression Scale
The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The construct being assessed is the caregiver depression. Best value = 0. Worst Value = 60.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startAug 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photozig, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruno Kajiyama, MS, Principal investigator, Photozig, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759863
- Sponsor's protocol ID
- Pz-A102b
- Other IDs
- R44AG022261
- Acronym
- Lifezig
- Status last verified
- Feb 2010
- First submitted
- 23 Sep 2008
- Last updated
- 2 Mar 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LifeZig System for Individuals With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00759863
- Acronym / sponsor ID
- Lifezig / Pz-A102b
- Conditions
- Alzheimer's Disease, Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Photozig, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 23 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LifeZig Project is a research study of a new reminiscence activity for individuals with Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with personalized video channels containing old photographs and music on television.
The goal of the LifeZig study is to enhance the quality of life for dementia patients and their families/caregivers, decrease the burden of care, and contribute to positive interaction between dementia patients and families/caregivers.
Detailed description
This program creates personalized TV channels with old photographs of AD patients, music, narration and relaxing sounds; as an activity to relax dementia patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifezig | Experimental | Behavioral: LifezigSubjects watch personalized reminiscence video channels developed by program staff with the help of family members/caregivers (using the LifeZig system) |
| Usual Care | No intervention | –Subjects follow routine activities applied by nurses or caregivers, such as traditional reminiscence, crafts, singing, recreational activities, and other activities. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LifezigAlso: LifeZig Personalized Reminiscence SlideshowPersonalized Reminiscence Video | Behavioural | Lifezig |
Primary outcome
Multidimensional Observation Scale for Elderly Subject
Time frame: 6 months
This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: "Personal Care", "Communication, Awareness \& Memory", "Mood", and "Interpersonal Awareness Behaviors". The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144.
2 secondary outcomes
Revised Memory and Behavior Problems Checklist
Time frame: 6 months
Center for Epidemiologic Studies Depression Scale
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bruno Kajiyama, MS principal investigator
Photozig, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lifezig in people with Alzheimer's Disease and Dementia, run by Photozig, 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 2 inclusion and 0 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 2 Mar 2010. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Multidimensional Observation Scale for Elderly Subject (time frame: 6 months). 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 2 Mar 2010.