DementiaPhase 1NCT00001777
Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)
A Phase 1 study testing Sertraline in people with Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Dementia refers to a condition where there is a loss of intellectual function (cognition). It is usually a progressive condition that interferes with normal social and occupational activities. Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found in the frontal lobe of the brain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Sertraline
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1997to May 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Characterized as having behavioral manifestations using a standardized neuropsychiatric scale and interview.
FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral test battery.
Patients must be able to be tested and cooperative with the procedures required in this protocol.
No contraindications to the use of Sertraline.
No medical conditions that can reasonably be expected to subject the patient to unwarranted risk (e.g., cancer) or require frequent changes in medication. Well-controlled medical conditions such as hypertension and diabetes will not be excluded.
Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age.
No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.
Not using any psychotropic medication which cannot be stopped 4 weeks before the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD)
Dementia refers to a condition where there is a loss of intellectual function (cognition). It is usually a progressive condition that interferes with normal social and occupational activities.
Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found in the frontal lobe of the brain. Loss of frontal lobe neurons can cause changes in personality, such as aggressiveness, agitation, and depression. In addition, patients with FLD may have difficulty planning tasks and may have a loss of motivation.
Read more
Researchers believe that the cells lost in the frontal lobe of the brain are responsible for producing a chemical called serotonin. Serotonin is a neurotransmitter, which means it is used by neurons to communicate with other neurons. Researchers are inclined to believe that by replacing the missing serotonin, symptoms of FLD may be relieved.
Drugs known as serotonin uptake inhibitors, help to maintain high levels of serotonin in the body. They have been used successfully to treat patients with depression and patients with violent / impulsive behaviors. Sertraline is a serotonin reuptake blocker that is relatively easy to give (once daily), is safer than most other serotonin reuptake blockers (very little effect on vital enzyme systems [cytochrome P-450]), and has few interactions with other drugs.
This study is designed to test the effectiveness of Sertraline for the treatment of symptoms associated with FLD. Patients participating in the study will receive Sertraline for 6 weeks and a placebo "inactive sugar pill" for 6 weeks. During the study, researchers will test psychological and neurological functions to measure the effects of the drug.
Read the detailed description
Degeneration of frontal serotonin-containing neurons occurs in frontal lobe dementia (FLD). The associated loss of serotonin transmission may contribute to the frontal lobe dysfunction associated with this disorder. FLD patients will undergo a controlled clinical trial of an orally administered serotonergic agent (Sertraline) which acts centrally to selectively block serotonin uptake to treat patients' cognitive and behavioral frontal dysfunction. Study subjects will be evaluated at regular intervals with a battery of neuropsychological and behavioral tests designed to assess frontal and other cognitive functions. In addition, compliance and levels of the medication will be measured in the blood and when possible in the cerebrospinal fluid (CSF).
- Conditions
- Dementia
- Being tested
- Sertraline
- Keywords
- Frontal Lobe Dementia, Serotonergic Transmission
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startDec 1997
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001777
- Sponsor's protocol ID
- 980046
- Other IDs
- 98-N-0046
- Status last verified
- Nov 1998
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Litvan I, Agid Y, Sastry N, Jankovic J, Wenning GK, Goetz CG, Verny M, Brandel JP, Jellinger K, Chaudhuri KR, McKee A, Lai EC, Pearce RK, Bartko JJ. What are the obstacles for an accurate clinical diagnosis of Pick's disease? A clinicopathologic study. Neurology. 1997 Jul;49(1):62-9. doi: 10.1212/wnl.49.1.62.
PubMed 9222171Sparks DL, Danner FW, Davis DG, Hackney C, Landers T, Coyne CM. Neurochemical and histopathologic alterations characteristic of Pick's disease in a non-demented individual. J Neuropathol Exp Neurol. 1994 Jan;53(1):37-42. doi: 10.1097/00005072-199401000-00005.
PubMed 8301318Swartz JR, Miller BL, Lesser IM, Darby AL. Frontotemporal dementia: treatment response to serotonin selective reuptake inhibitors. J Clin Psychiatry. 1997 May;58(5):212-6.
PubMed 9184615
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomized, Double-Blind Trial of Sertraline in Patients With Frontal Lobe Dementia (FLD)
- ClinicalTrials.gov ID
- NCT00001777
- Acronym / sponsor ID
- 980046
- Conditions
- Dementia
- Keywords
- Frontal Lobe Dementia, Serotonergic Transmission
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Dec 1997
- Study completion
- May 2000
- First posted
- 10 Dec 2002 (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.
Dementia refers to a condition where there is a loss of intellectual function (cognition). It is usually a progressive condition that interferes with normal social and occupational activities.
Patients with frontal lobe dementia (FLD) suffer from a destruction of the brain cells found in the frontal lobe of the brain. Loss of frontal lobe neurons can cause changes in personality, such as aggressiveness, agitation, and depression. In addition, patients with FLD may have difficulty planning tasks and may have a loss of motivation.
Researchers believe that the cells lost in the frontal lobe of the brain are responsible for producing a chemical called serotonin. Serotonin is a neurotransmitter, which means it is used by neurons to communicate with other neurons. Researchers are inclined to believe that by replacing the missing serotonin, symptoms of FLD may be relieved.
Drugs known as serotonin uptake inhibitors, help to maintain high levels of serotonin in the body. They have been used successfully to treat patients with depression and patients with violent / impulsive behaviors. Sertraline is a serotonin reuptake blocker that is relatively easy to give (once daily), is safer than most other serotonin reuptake blockers (very little effect on vital enzyme systems [cytochrome P-450]), and has few interactions with other drugs.
This study is designed to test the effectiveness of Sertraline for the treatment of symptoms associated with FLD. Patients participating in the study will receive Sertraline for 6 weeks and a placebo "inactive sugar pill" for 6 weeks. During the study, researchers will test psychological and neurological functions to measure the effects of the drug.
Detailed description
Degeneration of frontal serotonin-containing neurons occurs in frontal lobe dementia (FLD). The associated loss of serotonin transmission may contribute to the frontal lobe dysfunction associated with this disorder. FLD patients will undergo a controlled clinical trial of an orally administered serotonergic agent (Sertraline) which acts centrally to selectively block serotonin uptake to treat patients' cognitive and behavioral frontal dysfunction. Study subjects will be evaluated at regular intervals with a battery of neuropsychological and behavioral tests designed to assess frontal and other cognitive functions. In addition, compliance and levels of the medication will be measured in the blood and when possible in the cerebrospinal fluid (CSF).
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Sertraline | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 9222171Litvan I, Agid Y, Sastry N, Jankovic J, Wenning GK, Goetz CG, Verny M, Brandel JP, Jellinger K, Chaudhuri KR, McKee A, Lai EC, Pearce RK, Bartko JJ. What are the obstacles for an accurate clinical diagnosis of Pick's disease? A clinicopathologic study. Neurology. 1997 Jul;49(1):62-9. doi: 10.1212/wnl.49.1.62.
- Background: PubMed 8301318Sparks DL, Danner FW, Davis DG, Hackney C, Landers T, Coyne CM. Neurochemical and histopathologic alterations characteristic of Pick's disease in a non-demented individual. J Neuropathol Exp Neurol. 1994 Jan;53(1):37-42. doi: 10.1097/00005072-199401000-00005.
- Background: PubMed 9184615Swartz JR, Miller BL, Lesser IM, Darby AL. Frontotemporal dementia: treatment response to serotonin selective reuptake inhibitors. J Clin Psychiatry. 1997 May;58(5):212-6.
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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?
A Phase 1 study testing Sertraline in people with Dementia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001777, which also lists 3 linked publications.
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 4 Mar 2008.