DementiaPhase 1NCT00574054
Far Infrared Radiation Treatment of Dementia and Other Mental Illness
A Phase 1 study testing Far Infrared in people with Dementia, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
This trial is a preliminary study to determine the use of far infrared radiation for the treatment of dementia and other mental sickness. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Far Infrared
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Mar 2009
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons age 2 or older, with dementia, Alzheimer's, Huntington's disease, Parkinson's disease, Down's syndrome, multiple sclerosis or stroke
Who cannot join
- Persons with severe mental illness that are confined to mental hospitals etc., as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Dementia and Other Related Mental Illness.
This trial is a preliminary study to determine the use of far infrared radiation for the treatment of dementia and other mental sickness.
Read the detailed description
Dementia is the progressive decline in cognitive function due to damage or disease in the brain beyond what might be expected from normal aging. Particularly affected areas include memory, attention, language, and problem solving. Especially in the later stages of the condition, affected persons may be disoriented in place and in person (not knowing who they are).
The prevalence of dementia is rising as the global life expectancy is rising. Particularly in Western countries, there is increasing concern about the economic impact that dementia will have in future, older populaces.
It is a disease that is strongly associated with age; 1% of those aged 60-65, 6% of those aged 75-79, and 45% of those aged 95 or older suffer from the disease.
We are postulating that the use of far infrared radiation on the central nervous system, the endocrine system and the viscera will have a positive effect on treating dementia and other neurological illnesses.
- Conditions
- Dementia
- Being tested
- Far Infrared
- Keywords
- Familial Dementia, Semantic Dementia, Senile Paranoid Dementia
- Medical subject headings
- Dementia, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far InfraredRadiation
Far infrared radiation (5 μm to 20 μm wavelength) for 30 to 40 minutes per treatment session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Radiation: Far Infrared |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is to determine the therapeutic effects of far infrared radiation on dementia.
Measured: 1 year
Secondary outcomes (1)
The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related mental illness including Alzheimer's, multiple sclerosis and stroke rehabilitation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionJan 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Kwasi Donyina, Ph.D., Principal investigator, GAAD Medical Research Institute Inc.Ken Nedd, M.D., Study director, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574054
- Sponsor's protocol ID
- GAAD-DEM-CTP1
- Status last verified
- Aug 2009
- First submitted
- 12 Dec 2007
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Dementia and Other Related Mental Illness.
- ClinicalTrials.gov ID
- NCT00574054
- Acronym / sponsor ID
- GAAD-DEM-CTP1
- Conditions
- Dementia
- Keywords
- Familial Dementia, Semantic Dementia, Senile Paranoid Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 14 Dec 2007 (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.
This trial is a preliminary study to determine the use of far infrared radiation for the treatment of dementia and other mental sickness.
Detailed description
Dementia is the progressive decline in cognitive function due to damage or disease in the brain beyond what might be expected from normal aging. Particularly affected areas include memory, attention, language, and problem solving. Especially in the later stages of the condition, affected persons may be disoriented in place and in person (not knowing who they are).
The prevalence of dementia is rising as the global life expectancy is rising. Particularly in Western countries, there is increasing concern about the economic impact that dementia will have in future, older populaces.
It is a disease that is strongly associated with age; 1% of those aged 60-65, 6% of those aged 75-79, and 45% of those aged 95 or older suffer from the disease.
We are postulating that the use of far infrared radiation on the central nervous system, the endocrine system and the viscera will have a positive effect on treating dementia and other neurological illnesses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: Far Infrared |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Persons age 2 or older, with dementia, Alzheimer's, Huntington's disease, Parkinson's disease, Down's syndrome, multiple sclerosis or stroke
Key exclusion criteria (1 listed)
- Persons with severe mental illness that are confined to mental hospitals etc., as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM)
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 |
|---|---|---|
| Far InfraredFar infrared radiation (5 μm to 20 μm wavelength) for 30 to 40 minutes per treatment session. | Radiation | 1 |
Primary outcome
The primary end point is to determine the therapeutic effects of far infrared radiation on dementia.
Time frame: 1 year
1 secondary outcome
The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related mental illness including Alzheimer's, multiple sclerosis and stroke rehabilitation.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2009.
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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.
Kwasi Donyina, Ph.D. principal investigator
GAAD Medical Research Institute Inc.
Ken Nedd, M.D. study director
GAAD Medical Research Institute 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 Far Infrared in people with Dementia, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
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 1 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 17 Aug 2009. 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 Canada. 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?
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 end point is to determine the therapeutic effects of far infrared radiation on dementia. (time frame: 1 year). 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 17 Aug 2009.