Alzheimer's DiseaseNCT00703430
Memantine on Aggression and Agitation of Alzheimer's Disease (AD)
A study testing Memantine in people with Alzheimer's Disease, run by Peking University at 1 site in China.
Trial summary
Alzheimer's disease (AD), is associated with behavioral disturbances in approximately 50% of AD patients in Beijing. Agitation, and aggression specifically, is considered the most serious noncognitive symptom experienced in patients with dementia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Memantine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Jun 2014
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Clinical diagnosis of Alzheimer's disease.
- Having at least a minimum aggression score on the Cohen-Mansfield Agitation Inventory (CMAI): a score of ≥ 4 on at least 1 aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occurring at a frequency of 2 and 1 at a frequency of 3.
- Availability of a responsible family member or carer to ensure treatment compliance and provide information for informant assessments.
Who cannot join
- Unavailability of a responsible family member or carer
- Severe renal impairment.
- History of seizures
- Diagnosis of any concomitant life threatening illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Institute of Mental Health
Beijing, 100083
Huali Wang, MD, PhD, +86-10-82801983, dcrctraining@gmail.com
Huali Wang, MD, PhD
About this study
Official title: The Effect of Memantine on Aggression and Agitation and Its Impact on Caregiver Burden of Patients With Alzheimer's Disease: A 12-week Open-label Study
Alzheimer's disease (AD), is associated with behavioral disturbances in approximately 50% of AD patients in Beijing. Agitation, and aggression specifically, is considered the most serious noncognitive symptom experienced in patients with dementia. Memantine is a recognized treatment for Alzheimer's disease either alone or in combination with cholinesterase inhibitors. Its efficacy in vascular dementia is also established. Family members continue to play a central role in home care for the demented elderly in China. This proposal is to conduct a study in Beijing, China to investigate the efficacy and safety of Memantine in the treatment of agitation and aggression in AD patients. In addition, this proposal aims to explore the impact of memantine on caregiver burden of AD patients in Chinese culture.
- Conditions
- Alzheimer's Disease
- Being tested
- Memantine
- Keywords
- Alzheimer's disease, agitation, aggression, dementia
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation, Aggression, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Ebixa®
Initially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Memantine Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMAI score
Measured: 12 weeks
Secondary outcomes (3)
CBI score
Measured: 12 weeks
RUD
Measured: 12 weeks
NPI score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Principal investigator, Xin Yu, Peking University
- Investigators
- Xin Yu, MD, Principal investigator, Peking University Institute of Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703430
- Sponsor's protocol ID
- CN-IIT-12292
- Status last verified
- Jan 2013
- First submitted
- 20 Jun 2008
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Memantine on Aggression and Agitation and Its Impact on Caregiver Burden of Patients With Alzheimer's Disease: A 12-week Open-label Study
- ClinicalTrials.gov ID
- NCT00703430
- Acronym / sponsor ID
- CN-IIT-12292
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, agitation, aggression, dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Mar 2008
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 23 Jun 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.
Alzheimer's disease (AD), is associated with behavioral disturbances in approximately 50% of AD patients in Beijing. Agitation, and aggression specifically, is considered the most serious noncognitive symptom experienced in patients with dementia. Memantine is a recognized treatment for Alzheimer's disease either alone or in combination with cholinesterase inhibitors. Its efficacy in vascular dementia is also established. Family members continue to play a central role in home care for the demented elderly in China. This proposal is to conduct a study in Beijing, China to investigate the efficacy and safety of Memantine in the treatment of agitation and aggression in AD patients. In addition, this proposal aims to explore the impact of memantine on caregiver burden of AD patients in Chinese culture.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MemantineMemantine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Clinical diagnosis of Alzheimer's disease.
- Having at least a minimum aggression score on the Cohen-Mansfield Agitation Inventory (CMAI): a score of ≥ 4 on at least 1 aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occurring at a frequency of 2 and 1 at a frequency of 3.
- Availability of a responsible family member or carer to ensure treatment compliance and provide information for informant assessments.
Key exclusion criteria (4 listed)
- Unavailability of a responsible family member or carer
- Severe renal impairment.
- History of seizures
- Diagnosis of any concomitant life threatening illness.
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 |
|---|---|---|
| MemantineAlso: Ebixa®Initially Memantine 5mg/day, titrated within the first month to a maintenance dose of 20mg/day, which is maintained for the following 2 months. | Drug | 1 |
Primary outcome
CMAI score
Time frame: 12 weeks
3 secondary outcomes
CBI score
Time frame: 12 weeks
RUD
Time frame: 12 weeks
NPI score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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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.
Xin Yu, MD principal investigator
Peking University Institute of Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memantine in people with Alzheimer's Disease, run by Peking University at 1 site in China.
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 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 25 Jan 2013. 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 China. 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 Huali Wang, MD, PhD (+86-10-82801983, dcrctraining@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMAI score (time frame: 12 weeks). 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 25 Jan 2013.