Mood DisordersNCT00192998
The Serotonergic Transmitter System in Dementia and Affective Disorders
An observational study of Mood Disorders and Alzheimer Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this project is to examine the serotonergic transmitter system using functional imaging of the brain (positron emission tomography [PET]) to gain knowledge about early pathophysiological changes in Alzheimer's dementia and mood disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Alzheimer Disease
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2003to not given
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate to severe Alzheimer's disease
- Individuals genetically predisposed to affective disorder
- Healthy gender and age matched controls
Who cannot join
- Contraindications to magnetic resonance imaging (MRI)
- Use of psychoactive drugs
- Past or present affective disorder
- Other systemic diseases that may affect brain function
Trial locations and contacts
1 site in 1 country.
Steen G. Hasselbalch, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Neurobiological Research Unit
Copenhagen, 2100
Vibe G. Frokjaer, MD, +45 3545 6714, vibe@nru.dk
Vibe G. Frokjaer, MD
About this study
The aim of this project is to examine the serotonergic transmitter system using functional imaging of the brain (positron emission tomography [PET]) to gain knowledge about early pathophysiological changes in Alzheimer's dementia and mood disorders.
- Conditions
- Mood Disorders, Alzheimer Disease
- Keywords
- Affective disorder, Alzheimer dementia, healthy controls
- Medical subject headings
- Mood Disorders, Alzheimer Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Vibe G. Frokjaer, MD, Principal investigator, Neurobiological Research Unit, Copenhagen University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192998
- Sponsor's protocol ID
- SERT-AD
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 27 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Serotonergic Transmitter System in Dementia and Affective Disorders
- ClinicalTrials.gov ID
- NCT00192998
- Acronym / sponsor ID
- SERT-AD
- Conditions
- Mood Disorders, Alzheimer Disease
- Keywords
- Affective disorder, Alzheimer dementia, healthy controls
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2003
- First posted
- 19 Sep 2005 (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 aim of this project is to examine the serotonergic transmitter system using functional imaging of the brain (positron emission tomography [PET]) to gain knowledge about early pathophysiological changes in Alzheimer's dementia and mood disorders.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe Alzheimer's disease
- Individuals genetically predisposed to affective disorder
- Healthy gender and age matched controls
Key exclusion criteria (4 listed)
- Contraindications to magnetic resonance imaging (MRI)
- Use of psychoactive drugs
- Past or present affective disorder
- Other systemic diseases that may affect brain function
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2007.
- homepage for the neurobiological research unit, Copenhagen, DenmarkLink 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.
Steen G. Hasselbalch, MD contact
Vibe G. Frokjaer, MD principal investigator
Neurobiological Research Unit, Copenhagen University Hospital, Denmark
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 Mood Disorders and Alzheimer Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 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 27 Sep 2007. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vibe G. Frokjaer, MD (+45 3545 6714, vibe@nru.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 27 Sep 2007.