Alzheimer DiseasePhase 3NCT00255086

The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients

A Phase 3 study testing Memantine in people with Alzheimer Disease, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 95 years
Conditions the study is for: Alzheimer Disease
What is being tested?: Memantine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: May 2005to Feb 2010
Phase: Phase 3
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 to 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

2. 50-95 years of age inclusive.
3. MMSE at screen and baseline 7-28 inclusive.
4. Conversant in English.
5. Caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
6. Able to ingest oral medication. Exclusion Criteria:1. History of clinically significant stroke without substantial recovery.
2. Neurological or medical conditions causing significant disability independent of dementia.

Show all 16Show fewer

3. Parkinson's disease.
4. History in past two years of focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
5. Dementia due to Korsakoff's syndrome or infectious diseases such as Creutzfeldt-Jakob disease, herpes, encephalitis, or human immunodeficiency virus.
6. Sensory impairment that would prevent subject from participating in or cooperating with the protocol.
7. Significant clinical disorder or laboratory finding that renders the subject unsuitable for receiving an investigational drug including: clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality.
8. Clinical contraindication to the use of memantine (e.g., hypersensitivity).
9. History of seizure within past 5 years prior to screening.
10. Platelet count < 100,000/mm3.
11. History of claustrophobia
12. Presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Palo Alto Health Care System
Palo Alto, California, 94304

Other trials in United States

About this study

Official title: The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients: A Randomized, Placebo-Controlled, 52-Week Clinical Trial

The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In secondary analyses, we will determine if measures of clinical stabilization produced by memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS measures of brain NAA and MRI volumetric measures of hippocampal volume.

Read the detailed description

Alzheimer's disease (AD) is the most common form of dementia. Currently, there are more than 4 million individuals with dementia in the United States with at least 400,000 deaths annually. AD is a progressive, neurodegenerative disorder, characterized neuropathologically by widespread neuronal loss, presence of neurofibrillary tangles, and deposits of beta amyloid in cerebral blood vessels and neuritic plaques. Since the medial-temporal lobes, hippocampus, and association cortex are significantly impacted it is not surprising that the primary symptom of AD is a decline in cognitive functioning that leads to marked impairment in daily functioning. In particular, memory impairments, visuospatial decline, language difficulties, and loss of executive function are central cognitive symptoms of this illness. Behavioral disturbances such as agitation and hallucinations often accompany disease progression. The illness lasts approximately 7 to 10 years, with patients requiring total care in the latter stages. Thus, AD places a tremendous emotional and economic burden on both patients and their caregivers. Beyond a cure, therapeutic approaches which would alleviate the symptoms or delay progression could be of substantial psychological and economic benefit. Recent placebo controlled clinical trials have shown memantine to be efficacious in the treatment of patients with moderate to severe AD.

Conditions: Alzheimer Disease
Being tested: Memantine, Placebo pill
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MemantineDrug
Also called Namenda
10mg Memantine
Placebo pillDrug
Also called placebo
10mg placebo pill

Study groups in NCT00255086
Study group	Role	What they receive
Memantine	Experimental	10mg Memantine Receives: Drug: Memantine
Control	Placebo comparator	10 mg Placebo pill Receives: Drug: Placebo pill

What is being measured

The primary outcome is the main question the study is designed to answer.

NAA/Cr Ratio
To determine if memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of hippocampal n-acetyl aspartate (NAA) and magnetic resonance imaging volumetric measures (MRI) of hippocampal volume.
Measured: Baseline; Year 1

Secondary outcomes (1)

Mean Change on the ADAS-Cog Score After 1 Year
Progression of cognitive functioning as measured by performance on the Alzheimer's Disease (AD) Assessment Scale-cognitive subscale (ADAS-Cog). ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics, and measures disturbances of of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Responses are summed for an overall score which can range from 0-70. The greater the dysfunction, the higher the score. A typical score for a person without dementia is 5.
Measured: Baseline; Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Feb 2010

First posted17 Nov 2005 (estimated)
Study startMay 2005
Primary completionJun 2009
Study completionFeb 2010

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 Alzheimer DiseaseStudies of the same condition, open and under way.
More trials run by Stanford 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00255086
Sponsor's protocol ID: 95722
Status last verified: Feb 2017
First submitted: 15 Nov 2005
Last updated: 7 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients: A Randomized, Placebo-Controlled, 52-Week Clinical Trial
ClinicalTrials.gov ID: NCT00255086
Acronym / sponsor ID: 95722
Conditions: Alzheimer Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Palo Alto Veterans Institute for Research, Forest Laboratories
Study start: May 2005
Primary completion: Jun 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 17 Nov 2005 (estimated)
Results: Posted 7 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Memantine	Experimental	Drug: Memantine10mg Memantine
Control	Placebo comparator	Drug: Placebo pill10 mg Placebo pill

Who may qualify

Ages: 50 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

2. 50-95 years of age inclusive.
3. MMSE at screen and baseline 7-28 inclusive.
4. Conversant in English.
5. Caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.
6. Able to ingest oral medication. Exclusion Criteria:1. History of clinically significant stroke without substantial recovery.

Key exclusion criteria (0 listed)

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: Namenda10mg Memantine	Drug	Memantine
Placebo pillAlso: placebo10mg placebo pill	Drug	Control

Primary outcome

NAA/Cr Ratio
Time frame: Baseline; Year 1
To determine if memantine has a neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of hippocampal n-acetyl aspartate (NAA) and magnetic resonance imaging volumetric measures (MRI) of hippocampal volume.

1 secondary outcome

Mean Change on the ADAS-Cog Score After 1 Year
Time frame: Baseline; Year 1

Results and safety

Results posted to the registry on 7 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Memantine	9	7
Control	8	6

Primary outcome: NAA/Cr Ratio

Time frame: Baseline; Year 1. Mean (Standard Deviation). Unit: Ratio

Measure	Memantine n = 4	Control n = 6
Baseline	1.47 (0.11)	1.38 (0.10)
Year 1	1.62 (0.14)	1.41 (0.10)

Population analysed: Participants who could tolerate study medication and who completed the study were included in the analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Memantine	1 of 9 (11.1%)	4 of 9 (44.4%)	Not reported
Control	2 of 8 (25%)	0 of 8 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

J. Wesson Ashford Jr., MD, PhD study director

Stanford University

Jerome A Yesavage principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Memantine in people with Alzheimer Disease, run by Stanford University 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 16 inclusion and 0 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 7 Apr 2017. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Apr 2017). 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?

NAA/Cr Ratio (time frame: Baseline; Year 1). 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 NCT00255086.

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 7 Apr 2017.