DementiaDEMSPETNCT01112501
SPECT/CT in the Diagnosis of Dementia
An observational study of Dementia, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2) patient with possible symptoms and signs of frontotemporal dementia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 82 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2006to Jan 2010
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects with possible/suspected early dementia
Who may be able to join
- healthy control
- mild cognitive impairment (recruited from a population based data)
- clinically suspected frontotemporal dementia (unset diagnosis)
Who cannot join
- unable to be scanned with SPECT/CT
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2) patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT data is performed both by visual and quantitative voxel-based analyses (Statistical Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.
- Conditions
- Dementia
- Keywords
- Diagnosis, Dementia, Imaging
- Medical subject headings
- Dementia, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Final diagnosis
(1) controls, (2) stable mild cognitive impairment (MCI), (3)MCI converted to Alzheimers's disease (AD), (4) frontotemporal dementia (FTD), suspected FTD converted to AD, (5) other final diagnoses
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startSep 2006
- Primary completionJan 2010
- Study completionJan 2010
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112501
- Sponsor's protocol ID
- KUH5031339
- Acronym
- DEMSPET
- Status last verified
- Apr 2010
- First submitted
- 27 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT/CT in the Diagnosis of Dementia
- ClinicalTrials.gov ID
- NCT01112501
- Acronym / sponsor ID
- DEMSPET / KUH5031339
- Conditions
- Dementia
- Keywords
- Diagnosis, Dementia, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Sep 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 28 Apr 2010 (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.
Aim of the study is to evaluate whether Tc-99m-ECD-SPECT/CT enhances early diagnosis of dementia in two specific patient groups: (1) patient with mild cognitive impairment, and (2) patient with possible symptoms and signs of frontotemporal dementia. Evaluation of SPECT/CT data is performed both by visual and quantitative voxel-based analyses (Statistical Parametric Mapping). The final diagnosis is based on up to four years clinical follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with possible/suspected early dementia
Key inclusion criteria (3 listed)
- healthy control
- mild cognitive impairment (recruited from a population based data)
- clinically suspected frontotemporal dementia (unset diagnosis)
Key exclusion criteria (1 listed)
- unable to be scanned with SPECT/CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Final diagnosis
Time frame: 4 years
(1) controls, (2) stable mild cognitive impairment (MCI), (3)MCI converted to Alzheimers's disease (AD), (4) frontotemporal dementia (FTD), suspected FTD converted to AD, (5) other final diagnoses
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 28 Apr 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Kuopio University Hospital at 1 site in Finland.
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 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: finished, as of the sponsor's last update on 28 Apr 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 Finland. 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?
Final diagnosis (time frame: 4 years). 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 28 Apr 2010.