Huntington's DiseasePhase 4NCT00652457
Study of Memantine to Treat Huntington's Disease
A Phase 4 study testing Memantine in people with Huntington's Disease, run by Jody Corey-Bloom, MD, PhD at 3 sites in United States.
Trial summary
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- Memantine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Nov 2004to 28 Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 or older.
- Diagnosis of HD with current complaints of memory or concentration difficulties.
- Dementia Rating Scale score of <129, to ensure that patients have sufficient cognitive impairment.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Good general health with no additional diseases expected to interfere with the study.
- Patient is not institutionalized.
- Sufficient English skills to complete all testing without assistance of an English language interpreter.
- Availability of a responsible caregiver who agrees to supervise administration of study drug, monitor the patient's compliance and adverse events, and accompany the patient to all clinic visits.
Who cannot join
- 1. Any significant neurologic disease other than HD.
- Severe psychotic features or other severe psychiatric problems within the last three months which could lead to difficulty complying with the protocol.
- History of alcohol or substance abuse within the past two years (DSM IV criteria).
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
- History of MI in the past year or head trauma with loss of consciousness greater than 20 minutes.
- Insulin-requiring diabetes.
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- Use of any FDA approved cognitive enhancing prescription medications or investigational drugs within 30 days.
- Use of ginkgo biloba or DHEA within four weeks prior to baseline.
- Use of narcotic analgesics within 4 weeks prior to baseline.
- Patients who, in the investigator's opinion, would not comply with study procedures.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of California, San Diego
La Jolla, California, 92037
About this study
Official title: A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).
Read the detailed description
Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improved performance on psychometric tests of memory and executive functions in addition to behavior and that patients treated with memantine will show more improvement after six months than after three months of treatment.
- Conditions
- Huntington's Disease
- Being tested
- Memantine
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
10 mg BID x 3 months
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | Memantine 10 mg BID for three months Receives: Drug: Memantine |
| Placebo | Placebo comparator | Placebo 10 mg BID for three months Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)
The HVLT-R consists of 3 parts. Free recall has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.
Measured: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
Secondary outcomes (1)
Neuropsychiatric Inventory (NPI)
The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia.
The NPI Score is calculated by multiplying the total reported frequency by the severity score, with a theoretical range of 0-1704: high scores indicating greater frequency by severity.
The change between 2 or more time points is being reported.
Measured: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study start23 Nov 2004
- Primary completion28 Oct 2009
- Study completion28 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Huntington'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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jody Corey-Bloom, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor-investigator, Jody Corey-Bloom, MD, PhD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652457
- Sponsor's protocol ID
- MEM-HD
- Status last verified
- Dec 2020
- First submitted
- 31 Mar 2008
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Memantine for Cognitive and Behavioral Dysfunction in Huntington's Disease"
- ClinicalTrials.gov ID
- NCT00652457
- Acronym / sponsor ID
- MEM-HD
- Conditions
- Huntington's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jody Corey-Bloom, MD, PhDUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- 23 Nov 2004 (actual)
- Primary completion
- 28 Oct 2009 (actual)
- Study completion
- 28 Oct 2009 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if memantine in doses of 10 mg BID affects memory, cognition, and behavior in patients with Huntington's disease (HD).
Detailed description
Results of several published clinical trials suggest that memantine has a beneficial effect in dementing conditions, such as Alzheimer's disease; however, the effects of memantine on cognitive and behavioral function in HD are unknown. Our hypotheses are that HD patients who are administered memantine will show improved performance on psychometric tests of memory and executive functions in addition to behavior and that patients treated with memantine will show more improvement after six months than after three months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: MemantineMemantine 10 mg BID for three months |
| Placebo | Placebo comparator | Drug: MemantinePlacebo 10 mg BID for three months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women aged 18 or older.
- Diagnosis of HD with current complaints of memory or concentration difficulties.
- Dementia Rating Scale score of <129, to ensure that patients have sufficient cognitive impairment.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Good general health with no additional diseases expected to interfere with the study.
Key exclusion criteria (10 listed)
- 1. Any significant neurologic disease other than HD.
- Severe psychotic features or other severe psychiatric problems within the last three months which could lead to difficulty complying with the protocol.
- History of alcohol or substance abuse within the past two years (DSM IV criteria).
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
- History of MI in the past year or head trauma with loss of consciousness greater than 20 minutes.
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: Namenda10 mg BID x 3 months | Drug | Memantine, Placebo |
Primary outcome
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall)
Time frame: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
The HVLT-R consists of 3 parts. Free recall has a range of 0 to 36, delayed recall has a range from 0 to 12, and delayed recognition has a range of -12 to 12. Higher scores indicating better function in all 3 parts. Standardized scores are used by calculating an average standardized z score for each part of the HVLT-R. Change is calculated by subtracting baseline value from the respective later time point value. Imputation methods were used to determine values for all alive patients missing the post-baseline assessments. This tool is being used to measure cognitive function, specifically memory.
1 secondary outcome
Neuropsychiatric Inventory (NPI)
Time frame: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine in people with Huntington's Disease, run by Jody Corey-Bloom, MD, PhD at 3 sites in United States.
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 8 inclusion and 10 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 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?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) (time frame: Baseline, 3 months from start of drug treatment, 6 months from start of drug treatment). 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 5 Jan 2021.