2005 - Summary of Ongoing Memantine Trials
Purpose:
Create central point for ongoing Memantine trials.
Caution(s):
The word 'trial' is used herein in a loosey-goosey
fashion.
Indications presented below:
----------------------------
Alzheimer's Disease
MRI Assessment of Hippocampal Response
Autism
Aphasia - (Primary Progressive Aphasia)
Lupus (Dementia)
Major Depression
Neuropathic Pain
Schizophrenia
=============================
Forest Labs sponsored
=============================
Phase 3 - Moderate to Severe Ad
=============================
STATUS ENTROLLING
=============================
An Evaluation of the Safety and Efficacy of Memantine
in Agitated Patients with Moderate to Severe Alzheimer's Disease
This study is currently recruiting patients.
Sponsored by: Forest Laboratories
Information provided by: Forest Laboratories
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind,
Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Further Study Details:
Primary Outcomes: Neuropsychiatric Inventory
Secondary Outcomes: Cohen Mansfield Agitation Inventory;
Clinical Global Impression Scale; ADCS-ADL;
Agitation/aggression domain of Neuropsychiatric Inventory (NPI)
Expected Total Enrollment: 150
Study start: September 2004
clinicaltrials.gov
=============================
End
=============================
=============================
Lundbeck sponsored
=============================
Canadian Trial
=============================
Phase 3 - Moderate to Severe Ad
=============================
STATUS ENTROLLING
=============================
The Efficacy and Safety of Memantine in
Moderate to Severe Alzheimer Disease
What is the purpose of the study?
The purpose of the study is to evaluate the effect
of memantine on symptoms in people with moderate
to severe Alzheimer Disease. Behavioural symptoms,
cognitive and daily functioning, and quality of
life will specifically be evaluated. In this study,
memantine will be compared to a placebo (an inactive
substance) over a period of six months.
How large is the study?
The study intends to recruit approximately 1,000 participants
from multiple sites in Canada.
How is the study funded?
H. Lundbeck A/S is the sponsor of the study and
is funding the research.
Where are the study sites?
For information on study sites in Canada
contact expert@alzheimer.ca.
alzheimer.ca
=============================
End
=============================
=============================
Janssen Pharmaceutica sponsored (GUESSING)
=============================
Namenda / Reminyl combo trial for
Moderate to Severe
=============================
Phase NONE
=============================
STATUS ENTROLLING (GUESSING)
=============================
University of Medicine & Dentistry of New Jersey
2. We are seeking patients 50 years and older with
generally good health and diagnosed with Alzheimer's
disease to participate in a research study evaluating the
safety and effectiveness of memantine (Namenda"#8482;)
augmented with galantamine (Reminyl"#8482;) in the
treatment of patients with moderate to severe Alzheimer's
disease. Both these medications have been approved
by the FDA. This study will also look at what effect the
combination of these two medications has on memory and
day to day function.
Eligible subjects must be taking Reminyl"#8482; 16 or 24mg per day, be at a stable dose for at least 6 weeks prior to entering the study, and must continue at that dose for the entire study in order to participate. All study medications, which include both Reminyl"#8482; and Namenda"#8482;, will be
umdnj.edu
/articles.html
=============================
End
=============================
=============================
Memory Disorders Unit at Brigham
and Women’s Hospital
=============================
Summary: Functional MRI Assessment of
Hippocampal Response to Treatment
with Memantine
=============================
Phase NONE
=============================
STATUS ENTROLLING (GUESSING)
=============================
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).
Eligible subjects must be 50 years of age and older, have
a diagnosis of mild to moderate Alzheimer’s Disease with
an MMSE score of 16 to 24. Subjects are asked to come to the
clinic for 9 visits over 24 weeks. Subjects will undergo
4 functional MRI scans over the 24 week study, in addition
to memory tests and standard AD assessment measures. All
participants must have a reliable caregiver who is able to
provide information about the subject’s condition and to
monitor compliance to study medication. Study participants
will be reimbursed for parking or transportation costs and
paid $50 for completion of each fMRI scan. Partners
physicians who have patients who might be interested in
participating in the study should contact Dr. Dorene Rentz (e-mail drentz@partners.org), or Sara Talcott,
MA (stalcott@partners.org) at Brigham and Women’s Hospital
or call the Memory Disorders Unit Clinical Research Group
at (617) 732-8085 All information is kept completely confidential.
centerwatch.com
=============================
End
=============================
=============================
NOVARTIS
=============================
Exelon + Namenda
=============================
Phase NONE
=============================
STATUS COMPLETED
=============================
Note:I do not know how to READ the results
of this trial. Don't know if things got
better or worse or no change.
(The graph shows a MINUS 1.73 mean change.)
Results of an open-label, noncomparative study in
which Namenda™ was added to EXELON Treatment
Results based on Intent-To-Treat (ITT) population.
Prospective, 12-week, multicenter, single arm,
open-label, flexible dosing, historically controlled study
in patients (n=90) with mild to moderate AD (MMSE scores of 10 to 20)2
In this study, all patients were treated with EXELON and Namenda
Patients were treated with EXELON for a maximum duration
of 24 weeks prior to initiating Namenda therapy
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
=============================
End
=============================
=============================
End of Alzheimer's related Trials
=============================
=============================
Completed Trial
=============================
AUTISM - October, 2004
=============================
<<<<<<<<<<<
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
Note:Per other links it appears that a few doctors are
prescribing Namenda in certain cases related to
autism. However, there is no *real* trial that
shows a theraputic benefit.
Feel compelled to add - from my laymen's mind -
in as much as Memantine seems to screw around
with NMDA receptors (setting closed/open status)
I am not aware of any studies/abstracts/blurbs
by which anyone knows with minimum certainty
that doing this to a child is SAFE - I.E. over the
duration of their growing years. I cannot
say it is UNSAFE - I just don't know of any
studies or assumptions that indicate that it
IS safe. The only YOUNG study I am aware of
was done with young chickens and it was (appeared)
safe. But so what ......
=============================
End
=============================
=============================
Northwestern University sponsored (GUESSING)
=============================
Phase 2 - (GUESSING)
The Utility of Namenda® in the Treatment of
Primary Progressive Aphasia
=============================
STATUS ENTROLLING
=============================
STATUS: RECRUITING
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
Note:
How common is aphasia?
Aphasia affects about one million Americans - or 1 in 250 people - and is more common than Parkinson's Disease, cerebral palsy or muscular dystrophy.
More than 100,000 Americans acquire the disorder each year. However, most people have never heard of it.
More:
aphasia.org
=============================
End
=============================
=============================
Dr. Dimond sponsored
=============================
Phase 2 - Lupus (Dementia)
=============================
STATUS ENTROLLING
=============================
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.
“I think many patients with lupus are troubled
by the degree of cognitive impairment they
experience,” Dr. Diamond says. “It may be hard to find
the right word or remember things in a timely way,
and they may have to develop strategies
to keep track of things,” she says.
“The bottom line is that cognitive impairment in
lupus certainly impedes function for many people,
and it would be tremendous if there were a non-toxic
way to prevent it from occurring.”
In lupus, the immune system goes awry and attacks
the body’s own cells and tissue, especially the
skin, joints, blood, heart, lungs and kidneys.
It affects 1-1.5 million Americans and is a
leading cause of kidney disease, stroke and
cardiovascular disease in young women.
lupusresearchinstitute.org
=============================
End
=============================
=============================
NIH sponsored
=============================
Phase 3 - Major Depression
=============================
STATUS ENTROLLING
=============================
Study Type: Interventional
Study Design: Treatment, Efficacy
Official Title: An Investigation of the Antidepressant Efficacy of Memantine, an
NMDA Antagonist with Neurotrophic Properties in Major Depression
Further Study Details:
Expected Total Enrollment: 112
Study start: June 18, 2002
Major affective disorders are common, severe, chronic and often a life-threatening illness. Major depression contributes to significant morbidity and mortality.
Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Suicide is the cause of death in 10-20% of individuals with recurrent depressive disorders.
Despite the availability of a wide range of antidepressant drugs, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatment, despite adequate dosage, duration, and compliance. Thus, there is a clear need to develop novel and improved therapeutics for unipolar and bipolar depression. Recent preclinical studies suggest that
antidepressants may exert delayed indirect effects on the glutamatergic system.
Furthermore, a growing body of data suggests that mood disorders are associated with regional volumetric reductions, and cell loss and atrophy. It is thus noteworthy that lamotrigine, which, among other effects reduces glutamate release, has antidepressant effects, and a pilot study has suggested that NMDA antagonists may have antidepressant effects. Together, this data suggests that the
glutamatergic system may play a role in the pathophysiology and treatment of depression, and that agents, which more directly reduce glutamatergic neurotransmission, may represent a novel class of antidepressants.
Memantine (Akatinol memantine), an agent that is approved in Germany for dementia syndrome, Parkinson's disease has significant antiglutamatergic and neuroprotective properties, may prove to have antidepressant properties in
depressed patients. In this study, we propose to investigate the potential efficacy of memantine, an agent which reduces glutamatergic output via open-channel block of the NMDA receptor-associated ion channel. Most importantly,
memantine only blocks the channel during periods of abnormal, excessive activity, and leaves relatively spared normal neurotransmission. This finding is the basis
for the minimal side effect profile displayed by memantine.
Patients, ages 18 to 80, with a diagnosis of major depression (without psychotic features), will be randomized to double-blind treatment outpatient study to receive either memantine (5-20mg/day) or placebo for a period of 8 weeks.
Following this acute period, patients who fully respond could enter a 16-week continuation phase. Acute efficacy will be determined by demonstrating a greater response rate using specified criteria. Approximately 112 patients with acute
major depression will be enrolled in the study.
clinicaltrials.gov
=============================
End
=============================
=============================
Forest Labs sponsored
=============================
Phase 2 - Neuropathic Pain
=============================
STATUS UNKNOWN
=============================
Patient Count - UNKNOWN
=============================
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.
Notes (GUESSING):
(a) Expect to hear something about this trial
by June/July 2005
(b) The new dosage is one 38.5 mg pill.
frx.com
=============================
Comments of a Namenda user for Pain
=============================
June 2004
Has anyone tried this for pain? My doctor gave me samples to try on May 17; I
started taking 2.5 mg per day and I am now up to 15 mg per day. Today, June 2, is
my first day with no burn. It just happened suddenly--not a gradual improvement
like I expected.
I am to continue increasing the dosage until I reach 20 mg (10 mg in the morning
and 10 mg in the evening). I am still stiff and sore, but it is so wonderful not
to have that blasted burn.
Namenda is supposed to work in a similar fashion to ketamine--it blocks NMDA pain
receptors, whatever those are.
This is my first posting; I had little to contribute until now. I will keep you
posted of new developments.
My wishes for pain free days to all of you.
Midwest
=============================
This is a follow up to my original posting regarding Namenda which I have been
using since May 17. The great news is that this is my second day of No Burn;
however, there are still some shooting pains and I am still sore and stiff. Alas,
there is no option but to continue with more and more physical therapy.
The only side effect I have experienced so far is constipation; some people might
experience dizziness and confusion--according to studies. Namenda is approved for
treatment of Alzheimers and the doctor said I might feel more alert. I really
don't see any difference there--I am sleeping well now that I don't have burning
pain. Forest Laboratories is supposedly seeking FDA approval for this drug as
treatment for neuropathic pain. It is classified as an NMDA antagonist as is
ketamine and dextromethorphan (found in Robitussin). I am positive that it has
stopped my burning pain (at least for 2 days). Now if I could just find something
to help me do all this occupational therapy.
Wishing you all pain free days.
Midwest
brain.hastypastry.net
=============================
End
=============================
=============================
Forest Labs sponsored
=============================
Phase 2 - Schizophrenia
=============================
STATUS ENTROLLING
=============================
Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in
Schizophrenia Patients
This study is currently recruiting patients.
Sponsored by: Forest Laboratories
Information provided by: Forest Laboratories
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel
Assignment, Safety/Efficacy Study
Official Title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and
Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in
Schizophrenia Patients with Persistent Residual Symptoms
Further Study Details:
Primary Outcomes: Postive and Negative Symptom Scale (PANSS) - Total Score
Secondary Outcomes: Clinical Global Impression - Severity (CGI-S); PANNS - Postive
Score; PANSS - Negative Score; Calgary Depression Scale for Schizophrenia; Brief
Assessment of Cognition; Clinical Global Impression - Improvement
Expected Total Enrollment: 128
Study start: August 2004
clinicaltrials.gov
=============================
End
============================= |
