Frontotemporal Lobar DegenerationPhase 4NCT00187525
A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration
A Phase 4 study testing Memantine in people with Frontotemporal Lobar Degeneration, run by University of California, San Francisco.
Trial summary
This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this FDA-approved medication for Alzheimer's Disease in patients with FTLD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Frontotemporal Lobar Degeneration
- What is being tested?
- Memantine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2004to Oct 2006
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neary et al. Criteria for Frontotemporal Lobar Degeneration
- Age 40 -80
- CDR < 3 or MMSE > 15
- English Speaking
- Study Partner
Who cannot join
- Concurrent use of antipsychotic drugs or acetylcholinesterase inhibitors
About this study
This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome measures include cognitive batteries, rating scales for activities of daily living and neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for Alzheimer's disease.
- Conditions
- Frontotemporal Lobar Degeneration
- Being tested
- Memantine
- Medical subject headings
- Frontotemporal Lobar Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionOct 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frontotemporal Lobar DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187525
- Sponsor's protocol ID
- NAM-02A
- Status last verified
- Nov 2012
- First submitted
- 13 Sep 2005
- Last updated
- 12 Nov 2012
- Results posted
- No
Publications
Boxer AL, Lipton AM, Womack K, Merrilees J, Neuhaus J, Pavlic D, Gandhi A, Red D, Martin-Cook K, Svetlik D, Miller BL. An open-label study of memantine treatment in 3 subtypes of frontotemporal lobar degeneration. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):211-7. doi: 10.1097/WAD.0b013e318197852f.
PubMed 19812461
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52 Week Open Label Trial of Memantine for Frontotemporal Lobar Degeneration
- ClinicalTrials.gov ID
- NCT00187525
- Acronym / sponsor ID
- NAM-02A
- Conditions
- Frontotemporal Lobar Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- May 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 16 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.
This is a 52-week, multicenter, open label trial of memantine (Namenda) for frontotemporal lobar degeneration (FTLD). The goal is to determine the safety and tolerability of this FDA-approved medication for Alzheimer's Disease in patients with FTLD. Secondary outcome measures include cognitive batteries, rating scales for activities of daily living and neuropsychiatric symptoms. All patients receive the FDA-approved dose of this medication for Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neary et al. Criteria for Frontotemporal Lobar Degeneration
- Age 40 -80
- CDR < 3 or MMSE > 15
- English Speaking
- Study Partner
Key exclusion criteria (1 listed)
- Concurrent use of antipsychotic drugs or acetylcholinesterase inhibitors
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 |
|---|---|---|
| Memantine | 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 12 Nov 2012.
- Derived from this study: PubMed 19812461Boxer AL, Lipton AM, Womack K, Merrilees J, Neuhaus J, Pavlic D, Gandhi A, Red D, Martin-Cook K, Svetlik D, Miller BL. An open-label study of memantine treatment in 3 subtypes of frontotemporal lobar degeneration. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):211-7. doi: 10.1097/WAD.0b013e318197852f.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine in people with Frontotemporal Lobar Degeneration, run by University of California, San Francisco.
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 5 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 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 NCT00187525, which also lists 1 linked publication.
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 12 Nov 2012.