2005 - MEM Trial/Usage Update
Purpose:Gather Memantine Uses/Trials Info
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Definitions
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AD-MtoS = Alzheimer's - Moderate to Severe
AD-MtoM = Alzheimer's - Mild to Moderate
AD-PCD = Prevent Cognitive Decline
UNK-S = Unknown Sponsor
DEM-FTD = Frontotemporal Dementia
APPA = Aphasia-Primary Progressive Aphasia
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Indication Summary
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AD-MtoS [Ongoing]
AD-MtoS [Ongoing]
AD-MtoS [Ongoing] Namenda-Reminyl
AD-MtoS [Completed] Exelon-Namenda
AD-MtoM MRI Assessment of Hippocampal Response
AD-PCD Stanford University [Ongoing]
Catatonia [Usage]
DEM-FTD Ohio Statue University [Ongoing]
Huntington Trial [Completed]
Autism [Completed]
APPA Northwestern University [Ongoing]
Landau-Kleffner Syndrome [Usage]
Lupus Dementia [Ongoing]
Major Depression [Ongoing]
Neuropathic Pain [Completed?]
Schizophrenia [Ongoing]
Wernicke_Korsakoff_Syndrome [Usage]
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AD-MtoS - P3 - Ongoing
Forest Labs sponsored
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Official Title: A Randomized, Double-Blind, Placebo-Controlled
Evaluation of the Safety and Efficacy of Memantine in
Non-Institutionalized Agitated Patients with Moderate
to Severe Alzheimer's Disease
Expected Total Enrollment: 150
Study start: September 2004
clinicaltrials.gov
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AD-MtoS - P3 - Ongoing
Lundbeck sponsored
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The Efficacy and Safety of Memantine in
Moderate to Severe Alzheimer Disease
contact expert@alzheimer.ca.
alzheimer.ca
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AD-MtoS - P3 - Ongoing
Namenda + Reminyl
Janssen Pharmaceutica sponsored
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umdnj.edu
cles.html
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AD-MtoS - P3 - Completed
Exelon + Namenda
Novartis sponsored
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All patients were on a stable dose of EXELON (6 to12 mg/day)
for at least 2 weeks prior to the study
Patients on EXELON + Namenda combination therapy
experienced a 1.73-point mean change in ADAS-Cog score
from baseline (defined as patients stablized on EXELON)2
exelon.com
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AD-MtoM - P? - Ongoing
Memory Disorders Unit at Brigham and Women’s Hospital
Summary: Functional MRI Assessment of Hippocampal Response to Treatment
with Memantine
UNK-S
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The Memory Disorders Unit at Brigham and Women’s Hospital
is conducting a research study for patients with mild
to moderate Alzheimer’s disease (AD). The purpose of the
study is to evaluate the effects of the newly FDA
approved drug called memantine on memory using functional MRI (fMRI).
This study design is to test Memantine against placebo
(which contains no active medication) for 12 weeks, followed
by 12 weeks of open label (where everyone receives Memantine).
centerwatch.com
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AD-Prevent Cognitive Decline Stanford University
Treatment with Memantine in Women at Risk for Cognitive Decline
UNK-S
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We are currently studying the effectiveness of treatment with memantine among postmenopausal women at risk for cognitive decline. Memantine has already been shown to
offer benefits for patients with moderate-to-severe Alzheimer’s disease, but its effectiveness in preventing cognitive decline for those at-risk individuals without
Alzheimer’s disease has yet to be elucidated. Study participants must be between the ages of 50 and 65, and have a known risk factor for cognitive decline, such as a
personal or family history of mood disorder, hypothyroidism, family history of Alzheimer’s disease, or the APOE-4 allele (a genetic risk factor for Alzheimer’s
disease). Participants will be treated with memantine over a six-month period, during which time their regional cerebral metabolism and hippocampal volume will be evaluated
using PET scans. Neuropsychological performance will also be evaluated over the six-month period, with repeated assessment at three and six months. All participants
will receive free medication for the duration of the study. Call Stephanie Shelton at (650) 723-7845 for more information.
bne.stanford.edu
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Catatonia - [Usage]
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Namenda may be a useful adjunctive therapy to novel
antipsychotics in the effective treatment of
catatonic schizophrenia, currently the dose of
10mg BID has been most effective for selected patients.
Message 20996421
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DEM-FTD Ohio Statue University
Clinical drug trials to treat frontotemporal dementia: Memantine, MKC-231
UNK-S
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No further information available
neurology.med.ohio-state.edu
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Huntington Trial Results
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A few weeks ago, the results of a study using memantine in Huntington’s was published
(A. Beister, M. Gerlach, J. Neural Transmitters (2004) (Suppl) 68 117-122). This study was done in Germany and involved 27 HD participants who took the drug for 2 years. This study was “open label” and not placebo-controlled: each participant and doctor knew that memantine was being used. The drug was given in doses similar to that used in
Alzheimer’s. The results are messy, but promising. There is no pure “take home” message: But remember that results in the clinic are always messier than those coming from a lab.
People’s brains are (orders of magnitude) more complex than cells in a culture dish.
Message 20907713
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AUTISM - October, 2004 - Completed
UNK-S
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Dr. Michael Chez of Illinois presented an interesting
study of the use of the new drug memantine in 30 children with autism. This drug, marketed under the brand name Namenda, has been approved in the US for the past 6
months to treat the memory dysfunction associated with Alzheimer’s disease. The parent ratings were quite positive, with 26 out of 30 parent questionnaires suggesting
improvement in attention, motor planning, language, and self-stimulatory behavior.
There were no side effects reported. Dr. Chez is also scheduled to report the use of memantine in children with seizures in a separate presentation to the American
Epilepsy Society in December.
Those children, some of whom presumably had autism as the
cause of their seizures, showed improvements in the numbers of their seizures and also in behavior.
Although these 2 studies were not conducted in a blinded fashion , the results are encouraging, and suggest that this medication may be very useful in children with
autism, with or without a seizure disorder.
In addition, no lab tests are needed to
ensure safe use. Some of the antiseizure meds, such as Depakote, require periodic blood test monitoring to ensure safety.
asmonline.org
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Primary Progressive Aphasia
UNK-S
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The purpose of this study is to evaluate whether
Namenda® (memantine), currently an FDA approved medication
for Alzheimer’s Disease dementia, will reduce decline
in PPA patients.
Individuals between the ages of 40 and 80, with a current
diagnosis of PPA, and who are not currently taking
Namenda® are eligible to participate. Participation includes two treatment conditions;
active drug for six months and placebo for six months. Neither the experimenters nor the subjects will know what treatment condition they are in until the entire study is completed. The duration of the study is 15 months, and
participants will make five visits.
brain.northwestern.edu
Aphasia affects about one million Americans - or 1 in 250 people More than 100,000 Americans acquire the disorder each year. However, most people have never heard of it.
aphasia.org
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Landau-Kleffner Syndrome - Usage
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Message 20895983
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Lupus Dementia - P2 - Ongoing
UNK-S
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Dr. Dimond - August 2004
In the new study, a new Alzheimer’s drug Namenda
(memantine) was injected into brains of mice when the
integrity of the blood-brain barrier was forced
opened. This drug then protected these neurons from
certain death. The drug filled the receptors so that
the autoantibodies could not get into the cells to destroy them.
“The exciting thing is that drugs already exist which
can block the brain-cell receptor to which these
antibodies bind,” Dr. Diamond says.
“We’d have to learn how to give these drugs in humans
with lupus and that’s part of what clinical trials
would tell us,” Dr. Diamond says. “In future studies,
we hope to determine whether we should give the treatment
and who should get it.”
Currently, Dr. Diamond and colleagues are conducting
a study in approximately 200 people with lupus
to see if the findings are consistent with
the results of this mouse study.
lupusresearchinstitute.org
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Major Depression - P3 - Ongoing
NIH sponsored
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Official Title: An Investigation of the Antidepressant Efficacy of Memantine, an
NMDA Antagonist with Neurotrophic Properties in Major Depression
clinicaltrials.gov
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Neuropathic Pain - P2 - Completed (Best Guess)
Forest Labs sponsored
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YEAR = 2003
NEW YORK, Oct. 22 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that, based on a
recently completed analysis of a clinical trial evaluating memantine for neuropathic pain, the Company has
decided to proceed with an expanded clinical
program with the objective of obtaining approval for this indication.
In May, the Company announced that the study had failed to
demonstrate a statistically significant effect in
favor of memantine on the change from baseline in
nocturnal pain, the primary outcome measure, compared with placebo.
Although the results did not achieve statistical significance
at week 16 (the protocol-defined endpoint), the recently completed analysis found that weekly assessments did show a statistically significant effect for memantine compared to placebo on nocturnal pain, on every time point from week 1 through week 14.
In addition, patients with more severe pain at baseline demonstrated a statistically superior effect
of memantine on pain scores compared to placebo from week 3
through week 16.
The expanded clinical program will include a
new Phase II trial which will examine various neuropathic
pain conditions at different dosages. Based on the outcome
of this Phase II trial, additional placebo-controlled Phase III trials may be initiated, with the goal of generating sufficient clinical data for submission of a New
Drug Application (NDA) for the treatment of neuropathic pain. Forest anticipates the earliest potential submission of an NDA would be in 2006.
Presently there are more than 1.5 million people in the United States who suffer from neuropathic pain and there are limited options available for its treatment.
frx.com
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Schizophrenia - P2 - Ongoing
Forest Labs sponsored
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Evaluation of the Safety and Efficacy of
Memantine as Adjunctive Treatment in
Schizophrenia Patients
Expected Total Enrollment: 128
Study start: August 2004
clinicaltrials.gov
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Wernicke_Korsakoff_Syndrome - Usage
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Jan 2005
EDIT
In the meantime, get her to a neurologist ( and go armed with the information you get here like that Nursing CEU article and read all the archived posts), make sure she is
not drinking, and taking Thiamin supplements.
Also I can't say enough how the Exelon and Namenda (treatments for Alzhiemers) has helped her.
She also takes Seroquel ( an anti psychotic which helps with some of the delusions) We have been able to reduce that significantly since the Exelon and Namenda.
health.groups.yahoo.com
finance.messages.yahoo.com
0934110&mid=11669 |
