Dementia Associated With Parkinson's DiseasePhase 2MEMPDDNCT00630500
Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)
A Phase 2 study testing Memantine in people with Dementia Associated With Parkinson's Disease and Dementia With Lewy Bodies, run by Helse Stavanger HF at 4 sites in 3 countries.
Trial summary
A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia Associated With Parkinson's Disease, Dementia With Lewy Bodies
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Feb 2006to Mar 2009
- Phase
- Phase 2
- 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
Who may be able to join
- a diagnosis of Parkinson's disease (Larsen and Dupont, 1994) and dementia (DSM IV(1987; 1994), or Dementia with Lewy bodies (McKeith et al. Neurology 2005)
- mild-to-moderate or moderate dementia (i.e. MMSE 12-26, inclusive)
- the subject has given a written informed consent
- the subject is able and willing to comply with the study procedures and has a reliable caregiver (i.e. relative or nurse/nurse assistant who sees the patient at least weekly)
Who cannot join
- other brain disease of sufficient severity to cause dementia
- mental retardation
- terminal illness with life expectancy shorter than 6 months
- recent major changes in health status
- known epilepsy or previous convulsive seizure
- major depression
Show all 15Show fewer
- severe dementia as defined by a Mini-mental State Examination score of 12 or lower
- moderate to severe renal impairment (i.e. serum creatinine > 1,5 upper limit normal (ULN) or creatinin clearance < 40ml/minute/1,73 m2
- moderate or severe heart disease (NYHA III-IV)
- moderate or severe pulmonal disease
- moderate to severe hepatic impairment (bilirubin or transaminases > 2 times ULN
- women of childbearing potential (i.e. not post-menopausal and not taking contraceptive
- the subjects is lactating
- any laboratory value(s) exceeding the limits of normality if deemed to be clinically relevant by the study physician
- known allergies to the investigational product
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Mental Health Unit
Epping, Essex, CM16 6TN
King's COllege London
London, London, SE1 1UL
Norway1 site
Stavanger University Hospital, Old Age Psychiatry Clinic
Stavanger, 4005
Sweden1 site
Clinical Memory Research Unit, Neuropsychiatric Clinic, University Hospital Malmo
Malmö, 20502
About this study
Official title: A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.
- Being tested
- Memantine, Placebo
- Keywords
- Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Memantine, Placebo-controlled, Parallel group
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Tablets, 5 or 10 mg, twice daily
PlaceboDrug
Tablets corresponding to 5 or 10 mg, twice daily, 6 months
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Active comparator | Active treatment with memantine Receives: Drug: Memantine |
| Placebo | Placebo comparator | Placebo matching active study drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression of Change
Measured: Month 3 and 6 after baseline
Secondary outcomes (7)
MMSE
Measured: Month 3 and 6
Alzheimer's QUick Test
Measured: Month 3 and 6
Cognitive Drug Research test
Measured: Month 3 and 6
Neuropsychiatric Inventory
Measured: Month 3 and 6
Unified Parkinson's Disease Rating Scale, part III
Measured: Month 3 and 6
Epworth Sleep Scale
Measured: Month 3 and 6
Stavanger Sleep Scale
Measured: Month 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2006
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia Associated With Parkinson's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- King's College London, Lund University
- Responsible party
- Sponsor
- Investigators
- Dag Aarsland, MD, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630500
- Sponsor's protocol ID
- MEMPDD-130206
- Acronym
- MEMPDD
- Status last verified
- Feb 2009
- First submitted
- 27 Feb 2008
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
- ClinicalTrials.gov ID
- NCT00630500
- Acronym / sponsor ID
- MEMPDD / MEMPDD-130206
- Keywords
- Dementia associated with Parkinson's disease, Dementia with Lewy bodies, Memantine, Placebo-controlled, Parallel group
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- King's College London, Lund University
- Study start
- Feb 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Mar 2008 (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.
A 24-week placebo-controlled parallel group multicentre trial to study the safety and efficacy of memantine in patients with dementia associated with Parkinson's disease and dementia with Lewy bodies. It is hypothesized that memantine will be safe and well tolerated, and more effective than placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine | Active comparator | Drug: MemantineActive treatment with memantine |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching active study drug |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- a diagnosis of Parkinson's disease (Larsen and Dupont, 1994) and dementia (DSM IV(1987; 1994), or Dementia with Lewy bodies (McKeith et al. Neurology 2005)
- mild-to-moderate or moderate dementia (i.e. MMSE 12-26, inclusive)
- the subject has given a written informed consent
- the subject is able and willing to comply with the study procedures and has a reliable caregiver (i.e. relative or nurse/nurse assistant who sees the patient at least weekly)
Key exclusion criteria (15 listed)
- other brain disease of sufficient severity to cause dementia
- mental retardation
- terminal illness with life expectancy shorter than 6 months
- recent major changes in health status
- known epilepsy or previous convulsive seizure
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 |
|---|---|---|
| MemantineTablets, 5 or 10 mg, twice daily | Drug | Memantine |
| PlaceboTablets corresponding to 5 or 10 mg, twice daily, 6 months | Drug | Placebo |
Primary outcome
Clinical Global Impression of Change
Time frame: Month 3 and 6 after baseline
7 secondary outcomes
MMSE
Time frame: Month 3 and 6
Alzheimer's QUick Test
Time frame: Month 3 and 6
Cognitive Drug Research test
Time frame: Month 3 and 6
Neuropsychiatric Inventory
Time frame: Month 3 and 6
Unified Parkinson's Disease Rating Scale, part III
Time frame: Month 3 and 6
Epworth Sleep Scale
Time frame: Month 3 and 6
Stavanger Sleep Scale
Time frame: Month 3 and 6
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 Jul 2015.
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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.
Dag Aarsland, MD, PhD principal investigator
Helse Stavanger HF
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine in people with Dementia Associated With Parkinson's Disease and Dementia With Lewy Bodies, run by Helse Stavanger HF at 4 sites in 3 countries.
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 4 inclusion and 15 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 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Norway, Sweden. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Clinical Global Impression of Change (time frame: Month 3 and 6 after baseline). 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 Jul 2015.