Alzheimer DiseasePhase 4NCT00551161
Magnetic Resonance Spectroscopy Study of Memantine in Alzheimer's Disease
A Phase 4 study testing memantine in people with Alzheimer Disease, run by Northwell Health at 1 site in United States.
Trial summary
We are studying subjects with mild to moderate Alzheimer's disease who have been on a stable dose of any cholinesterase inhibitor [donepezil (Aricept), rivastigmine (Exelon), or galantamine (Razadyne)] for at least 3 months, and have not previously taken memantine (Namenda). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained from either the subject (if they have decisional capacity) or a Legally Authorized Representative (LAR) (as required by state or local law and the IRB), prior to the initiation of any study-specific procedures. (If a subject is unable to fully consent for himself/herself, but has capacity to appoint a research proxy, the legally authorized research proxy will be asked to sign consent, with the subject signing assent.)
- Male or female outpatients at least 50 years of age at Screening.
- If female, the patient must be at least two years postmenopausal or surgically sterile at Screening.
- The patient has a current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria.
- The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study.
- Mini-Mental State Examination (MMSE) score of at least 15 and not greater than 26 at Screening.
Show all 11Show fewer
- Ongoing therapy with a stable dose of donepezil, rivastigmine, or galantamine for at least three months at the time of Screening.
- Physical examination, laboratory evaluations, and EKG results at Screening must be normal, or abnormal findings must be judged not clinically significant by the Investigator.
- The patient's MRI scan conducted as part of Screening (Visit 1) must be consistent with a diagnosis of Alzheimer's disease, and must not include any findings that could confound the spectroscopic analysis of subsequent MRIs (e.g., large cortical stroke, tumor, or other space-occupying brain lesions).
- Vision and hearing (hearing aid permissible) must be sufficient for compliance with testing procedures.
- The patient and/or their Legally Authorized Representative, and their caregiver must be able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments.
Who cannot join
- Clinically significant vitamin B12 deficiency at Screening.
- Patients with a modified Hachinski ischemia score greater than 4 at Screening.
- Patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease. Patients with controlled hypertension and right bundle branch block (complete or partial) may be included in the study. Patients with thyroid disease may also be included in the study provided they are euthyroid on treatment. Patients with controlled diabetes may also be included.
- Patients with severe renal impairment (estimated creatinine clearance < 35 mL/min).
- Patients with systolic blood pressure (while sitting) greater then than 180 mm Hg or less then 90 mm Hg, or diastolic blood pressure (while sitting) greater than 100 mm Hg or less than 50 mm Hg at Screening.
- Patients with evidence of other neurological disorders including, but not limited to, stroke, Parkinson's disease, seizure disorder, hydrocephalus, or head injury with loss of consciousness within the past five years at Screening.
Show all 20Show fewer
- Patients with a current DSM-IV Axis I disorder other than Alzheimer's disease, including schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic disorder, or post-traumatic stress disorder.
- Patients with dementia complicated by other organic disease.
- Patients who have had a previous brain scan (MRI or CT) with results inconsistent with a diagnosis of probable Alzheimer's disease.
- Patients with an oncological diagnosis (hematological or solid tumor) which is currently being treated, or for which there has been treatment within the year preceding Screening, or for which there is still evidence of active disease. (Note: Patients with local dermatological tumors at such as basal or squamous cell carcinoma may be included.)
- Patients with an object in the head or neck which would invalidate or obstruct the successful completion of an MRI scan, or patients who have other contraindications to MRI, including those with implanted ferromagnetic material or devices such as cardiac pacemakers, deep brain stimulators, cochlear implants, or intraocular metallic shards.
- Patients who are claustrophobic and/or unable to tolerate MRI at Screening, or whom the Investigator believes will not be able to tolerate further scans scheduled during the course of the study.
- Patients with a known or suspected history (within the past 5 years at Screening) of alcoholism or drug abuse.
- Patients who are on an unstable dose of a cholinesterase inhibitor (donepezil, rivastigmine, or galantamine), are currently taking more than one cholinesterase inhibitor at Screening, who are likely to require a change in cholinesterase drug dose during the course of the study, or for whom a cholinesterase inhibitor therapy is contraindicated.
- Patients with a history of severe drug allergy or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine, rimantadine, or lactose.
- Patients who have been previously treated with or have participated in an investigational study of neramexane, memantine, or amantadine.
- Patients previously treated with commercial memantine.
- Patients who have been in an investigational drug study or who have received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) of Screening.
- Patients or caregivers who are unwilling or unable to abide by the visit schedule and other requirements of the study.
- Any condition which would make the patient or caregiver unsuitable for the study in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Litwin-Zucker Research Center
Manhasset, New York, 11030
About this study
Official title: An Open-label Exploratory Study With Memantine: Correlation Between Proton Magnetic Resonance Spectroscopy, Cerebrospinal Fluid Biomarkers, and Cognition in Patients With Mild to Moderate Alzheimer's Disease
We are studying subjects with mild to moderate Alzheimer's disease who have been on a stable dose of any cholinesterase inhibitor [donepezil (Aricept), rivastigmine (Exelon), or galantamine (Razadyne)] for at least 3 months, and have not previously taken memantine (Namenda). This is an open-label study, with magnetic resonance spectroscopy (MRS) as the primary outcome measure, along with neuropsychological testing, and optional lumbar puncture, evaluating patients on their stable dose of a cholinesterase inhibitor over 24 weeks, followed by another 24 weeks on memantine in combination with stable dose of cholinesterase inhibitor. The purpose of this study is to characterize the progression of disease using MRS, cerebrospinal fluid (CSF) biomarkers, and cognitive outcome measures, and to determine whether changes in cognitive function on neuropsychological testing are correlated to changes in MR spectroscopic and/or CSF biomarkers.
Read the detailed description
Alzheimer's disease (AD) is the most common cause of dementia. The current US prevalence is estimated at over 4 million people, and it ranks as the 8th leading cause of mortality in the United States, accounting for over 60,000 deaths per year.
Memantine is the newest medication approved by the FDA for the treatment of AD. Since it works on a different transmitter system, it can be used in combination with the other FDA-approved treatments for AD, tacrine, donepezil, rivastigmine, or galantamine (collectively referred to as cholinesterase inhibitors).
It remains to be determined what effect currently available AD treatments have on the underlying structural and functional correlates of the dementia process. While preclinical evidence suggests that memantine decreases neuronal toxicity in vitro, it is not clear whether this translates into a beneficial effect in patients with AD.
One of the most pressing challenges underlying clinical trials in AD is the need to validate reliable surrogate biomarkers of disease progression. Proton magnetic resonance spectroscopy (MRS) allows for in vivo detection and measurement of brain metabolites. The spectroscopic features that have been most consistently observed in AD patients, as compared with patients with other causes of dementia, or with normal subjects, have been elevated myo-inositol (mI) and reduced N-acetylaspartate (NAA) .
Evaluation of cerebrospinal fluid (CSF) via lumbar puncture affords a minimally invasive window into the biochemical substrate enveloping the brain. Multiple previous studies of AD patients compared with control subjects have demonstrated decreased CSF beta-amyloid, and elevated CSF tau protein. Previous longitudinal studies have documented the stability of CSF beta-amyloid over one year and CSF tau over two years in AD, suggesting that these may be possible stable target measures for therapeutic intervention.
The purpose of this study is to characterize the progression of disease using MRS, CSF biomarkers, and cognitive outcome measures in patients with mild to moderate Alzheimer's disease after 24 weeks of observational treatment with stable dose of a cholinesterase inhibitor, and after another 24 weeks of open-label memantine treatment in addition to stable dose of a cholinesterase inhibitor.
- Conditions
- Alzheimer Disease
- Being tested
- memantine
- Keywords
- Alzheimer disease, memantine, cholinesterase inhibitors, magnetic resonance spectroscopy, N-acetylaspartate, inositol, cerebrospinal fluid, tau proteins, amyloid beta-protein
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memantineDrug
Also called Namenda
24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 10 mg orally b.i.d., in addition to their ongoing stable cholinesterase inhibitor treatment
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | 24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment Receives: Drug: memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 [(t2 - t1) - (t1 - t0)].
Measured: Baseline, 24 weeks, and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2011
- Study completionDec 2011
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.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Marc L Gordon, Northwell Health
- Investigators
- Marc L Gordon, M.D., Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551161
- Sponsor's protocol ID
- NAM-MD-50
- Status last verified
- Dec 2013
- First submitted
- 29 Oct 2007
- Last updated
- 28 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Adalsteinsson E, Sullivan EV, Kleinhans N, Spielman DM, Pfefferbaum A. Longitudinal decline of the neuronal marker N-acetyl aspartate in Alzheimer's disease. Lancet. 2000 May 13;355(9216):1696-7. doi: 10.1016/s0140-6736(00)02246-7.
PubMed 10905250Anderson RN, Smith BL. Deaths: leading causes for 2002. Natl Vital Stat Rep. 2005 Mar 7;53(17):1-89.
PubMed 15786629Andreasen N, Hesse C, Davidsson P, Minthon L, Wallin A, Winblad B, Vanderstichele H, Vanmechelen E, Blennow K. Cerebrospinal fluid beta-amyloid(1-42) in Alzheimer disease: differences between early- and late-onset Alzheimer disease and stability during the course of disease. Arch Neurol. 1999 Jun;56(6):673-80. doi: 10.1001/archneur.56.6.673.
PubMed 10369305Benton A, Hannay HJ, Varney NR. Visual perception of line direction in patients with unilateral brain disease. Neurology. 1975 Oct;25(10):907-10. doi: 10.1212/wnl.25.10.907.
PubMed 1237101Buschke, H. Selective reminding for analysis of memory and learning. J Verb Learn and Verb Behav 12:543-550, 1975.
Buschke H, Fuld PA. Evaluating storage, retention, and retrieval in disordered memory and learning. Neurology. 1974 Nov;24(11):1019-25. doi: 10.1212/wnl.24.11.1019. No abstract available.
PubMed 4473151Chen HS, Pellegrini JW, Aggarwal SK, Lei SZ, Warach S, Jensen FE, Lipton SA. Open-channel block of N-methyl-D-aspartate (NMDA) responses by memantine: therapeutic advantage against NMDA receptor-mediated neurotoxicity. J Neurosci. 1992 Nov;12(11):4427-36. doi: 10.1523/JNEUROSCI.12-11-04427.1992.
PubMed 1432103Cohen JR, Elvevag B, Goldberg TE. Cognitive control and semantics in schizophrenia: an integrated approach. Am J Psychiatry. 2005 Oct;162(10):1969-71. doi: 10.1176/appi.ajp.162.10.1969.
PubMed 16199848Dixon RM, Bradley KM, Budge MM, Styles P, Smith AD. Longitudinal quantitative proton magnetic resonance spectroscopy of the hippocampus in Alzheimer's disease. Brain. 2002 Oct;125(Pt 10):2332-41. doi: 10.1093/brain/awf226.
PubMed 12244089Frederick BD, Lyoo IK, Satlin A, Ahn KH, Kim MJ, Yurgelun-Todd DA, Cohen BM, Renshaw PF. In vivo proton magnetic resonance spectroscopy of the temporal lobe in Alzheimer's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1313-22. doi: 10.1016/j.pnpbp.2004.08.013.
PubMed 15588758Hamsher KD, Roberts RJ. Memory for recent U.S. presidents in patients with cerebral disease. J Clin Exp Neuropsychol. 1985 Feb;7(1):1-13. doi: 10.1080/01688638508401238.
PubMed 3980677Hoyert DL, Kung HC, Smith BL. Deaths: preliminary data for 2003. Natl Vital Stat Rep. 2005 Feb 28;53(15):1-48.
PubMed 15779680Huang W, Alexander GE, Chang L, Shetty HU, Krasuski JS, Rapoport SI, Schapiro MB. Brain metabolite concentration and dementia severity in Alzheimer's disease: a (1)H MRS study. Neurology. 2001 Aug 28;57(4):626-32. doi: 10.1212/wnl.57.4.626.
PubMed 11524470Jessen F, Traeber F, Freymann K, Maier W, Schild HH, Block W. Treatment monitoring and response prediction with proton MR spectroscopy in AD. Neurology. 2006 Aug 8;67(3):528-30. doi: 10.1212/01.wnl.0000228218.68451.31.
PubMed 16894124Keilhoff G, Wolf G. Memantine prevents quinolinic acid-induced hippocampal damage. Eur J Pharmacol. 1992 Sep 4;219(3):451-4. doi: 10.1016/0014-2999(92)90487-o.
PubMed 1425971
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Exploratory Study With Memantine: Correlation Between Proton Magnetic Resonance Spectroscopy, Cerebrospinal Fluid Biomarkers, and Cognition in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00551161
- Acronym / sponsor ID
- NAM-MD-50
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, memantine, cholinesterase inhibitors, magnetic resonance spectroscopy, N-acetylaspartate, inositol, cerebrospinal fluid, tau proteins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Aug 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Oct 2007 (estimated)
- Results
- Posted 18 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are studying subjects with mild to moderate Alzheimer's disease who have been on a stable dose of any cholinesterase inhibitor [donepezil (Aricept), rivastigmine (Exelon), or galantamine (Razadyne)] for at least 3 months, and have not previously taken memantine (Namenda). This is an open-label study, with magnetic resonance spectroscopy (MRS) as the primary outcome measure, along with neuropsychological testing, and optional lumbar puncture, evaluating patients on their stable dose of a cholinesterase inhibitor over 24 weeks, followed by another 24 weeks on memantine in combination with stable dose of cholinesterase inhibitor. The purpose of this study is to characterize the progression of disease using MRS, cerebrospinal fluid (CSF) biomarkers, and cognitive outcome measures, and to determine whether changes in cognitive function on neuropsychological testing are correlated to changes in MR spectroscopic and/or CSF biomarkers.
Detailed description
Alzheimer's disease (AD) is the most common cause of dementia. The current US prevalence is estimated at over 4 million people, and it ranks as the 8th leading cause of mortality in the United States, accounting for over 60,000 deaths per year.
Memantine is the newest medication approved by the FDA for the treatment of AD. Since it works on a different transmitter system, it can be used in combination with the other FDA-approved treatments for AD, tacrine, donepezil, rivastigmine, or galantamine (collectively referred to as cholinesterase inhibitors).
It remains to be determined what effect currently available AD treatments have on the underlying structural and functional correlates of the dementia process. While preclinical evidence suggests that memantine decreases neuronal toxicity in vitro, it is not clear whether this translates into a beneficial effect in patients with AD.
One of the most pressing challenges underlying clinical trials in AD is the need to validate reliable surrogate biomarkers of disease progression. Proton magnetic resonance spectroscopy (MRS) allows for in vivo detection and measurement of brain metabolites. The spectroscopic features that have been most consistently observed in AD patients, as compared with patients with other causes of dementia, or with normal subjects, have been elevated myo-inositol (mI) and reduced N-acetylaspartate (NAA) .
Evaluation of cerebrospinal fluid (CSF) via lumbar puncture affords a minimally invasive window into the biochemical substrate enveloping the brain. Multiple previous studies of AD patients compared with control subjects have demonstrated decreased CSF beta-amyloid, and elevated CSF tau protein. Previous longitudinal studies have documented the stability of CSF beta-amyloid over one year and CSF tau over two years in AD, suggesting that these may be possible stable target measures for therapeutic intervention.
The purpose of this study is to characterize the progression of disease using MRS, CSF biomarkers, and cognitive outcome measures in patients with mild to moderate Alzheimer's disease after 24 weeks of observational treatment with stable dose of a cholinesterase inhibitor, and after another 24 weeks of open-label memantine treatment in addition to stable dose of a cholinesterase inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Drug: memantine24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent must be obtained from either the subject (if they have decisional capacity) or a Legally Authorized Representative (LAR) (as required by state or local law and the IRB), prior to the initiation of any study-specific procedures. (If a subject is unable to fully consent for himself/herself, but has capacity to appoint a research proxy, the legally authorized research proxy will be asked to sign consent, with the subject signing assent.)
- Male or female outpatients at least 50 years of age at Screening.
- If female, the patient must be at least two years postmenopausal or surgically sterile at Screening.
- The patient has a current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA criteria.
- The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the course of the study.
Key exclusion criteria (20 listed)
- Clinically significant vitamin B12 deficiency at Screening.
- Patients with a modified Hachinski ischemia score greater than 4 at Screening.
- Patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease. Patients with controlled hypertension and right bundle branch block (complete or partial) may be included in the study. Patients with thyroid disease may also be included in the study provided they are euthyroid on treatment. Patients with controlled diabetes may also be included.
- Patients with severe renal impairment (estimated creatinine clearance < 35 mL/min).
- Patients with systolic blood pressure (while sitting) greater then than 180 mm Hg or less then 90 mm Hg, or diastolic blood pressure (while sitting) greater than 100 mm Hg or less than 50 mm Hg at Screening.
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: Namenda24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 10 mg orally b.i.d., in addition to their ongoing stable cholinesterase inhibitor treatment | Drug | single-arm |
Primary outcome
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor
Time frame: Baseline, 24 weeks, and 48 weeks
Ratios of myo-inositol (mI), N-acetylaspartate (NAA), total creatine (Cr), and choline (Cho) by single voxel 1H MRS (proton magnetic resonance spectroscopy). Mean (± SD) metabolite levels (normalized to T2-corrected water signal intensity) and metabolite ratios for Alzheimer's disease subjects at baseline (t0), after 24 weeks of ongoing monotherapy with stable-dose cholinesterase inhibitor (t1), and after another 24 weeks of combination therapy with memantine in addition to stable-dose cholinesterase inhibitor (t2). The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 [(t2 - t1) - (t1 - t0)].
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10905250Adalsteinsson E, Sullivan EV, Kleinhans N, Spielman DM, Pfefferbaum A. Longitudinal decline of the neuronal marker N-acetyl aspartate in Alzheimer's disease. Lancet. 2000 May 13;355(9216):1696-7. doi: 10.1016/s0140-6736(00)02246-7.
- Background: PubMed 15786629Anderson RN, Smith BL. Deaths: leading causes for 2002. Natl Vital Stat Rep. 2005 Mar 7;53(17):1-89.
- Background: PubMed 10369305Andreasen N, Hesse C, Davidsson P, Minthon L, Wallin A, Winblad B, Vanderstichele H, Vanmechelen E, Blennow K. Cerebrospinal fluid beta-amyloid(1-42) in Alzheimer disease: differences between early- and late-onset Alzheimer disease and stability during the course of disease. Arch Neurol. 1999 Jun;56(6):673-80. doi: 10.1001/archneur.56.6.673.
- Background: PubMed 1237101Benton A, Hannay HJ, Varney NR. Visual perception of line direction in patients with unilateral brain disease. Neurology. 1975 Oct;25(10):907-10. doi: 10.1212/wnl.25.10.907.
- BackgroundBuschke, H. Selective reminding for analysis of memory and learning. J Verb Learn and Verb Behav 12:543-550, 1975.
- Background: PubMed 4473151Buschke H, Fuld PA. Evaluating storage, retention, and retrieval in disordered memory and learning. Neurology. 1974 Nov;24(11):1019-25. doi: 10.1212/wnl.24.11.1019. No abstract available.
- Background: PubMed 1432103Chen HS, Pellegrini JW, Aggarwal SK, Lei SZ, Warach S, Jensen FE, Lipton SA. Open-channel block of N-methyl-D-aspartate (NMDA) responses by memantine: therapeutic advantage against NMDA receptor-mediated neurotoxicity. J Neurosci. 1992 Nov;12(11):4427-36. doi: 10.1523/JNEUROSCI.12-11-04427.1992.
- Background: PubMed 16199848Cohen JR, Elvevag B, Goldberg TE. Cognitive control and semantics in schizophrenia: an integrated approach. Am J Psychiatry. 2005 Oct;162(10):1969-71. doi: 10.1176/appi.ajp.162.10.1969.
- Background: PubMed 12244089Dixon RM, Bradley KM, Budge MM, Styles P, Smith AD. Longitudinal quantitative proton magnetic resonance spectroscopy of the hippocampus in Alzheimer's disease. Brain. 2002 Oct;125(Pt 10):2332-41. doi: 10.1093/brain/awf226.
- Background: PubMed 15588758Frederick BD, Lyoo IK, Satlin A, Ahn KH, Kim MJ, Yurgelun-Todd DA, Cohen BM, Renshaw PF. In vivo proton magnetic resonance spectroscopy of the temporal lobe in Alzheimer's disease. Prog Neuropsychopharmacol Biol Psychiatry. 2004 Dec;28(8):1313-22. doi: 10.1016/j.pnpbp.2004.08.013.
- Background: PubMed 3980677Hamsher KD, Roberts RJ. Memory for recent U.S. presidents in patients with cerebral disease. J Clin Exp Neuropsychol. 1985 Feb;7(1):1-13. doi: 10.1080/01688638508401238.
- Background: PubMed 15779680Hoyert DL, Kung HC, Smith BL. Deaths: preliminary data for 2003. Natl Vital Stat Rep. 2005 Feb 28;53(15):1-48.
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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.
Marc L Gordon, M.D. principal investigator
Northwell Health
1 site 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 Alzheimer Disease, run by Northwell Health at 1 site 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 11 inclusion and 20 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 Jan 2014. 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 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 18 Dec 2013). 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?
Changes in the Metabolite Ratios of N-acetylaspartate (NAA) to Creatine (Cr), Myo-inositol (mI) to Cr, Choline (Cho) to Cr, NAA to Cho, and NAA to mI, on Cholinesterase Monotherapy vs Combination of Memantine and Cholinesterase Inhibitor (time frame: Baseline, 24 weeks, and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00551161, which also lists 22 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 28 Jan 2014.