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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00255086
Recruitment Status : Completed
First Posted : November 17, 2005
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Collaborators:
Palo Alto Veterans Institute for Research
Forest Laboratories
Information provided by (Responsible Party):
Jerome A Yesavage,, Stanford University

Tracking Information
First Submitted Date  ICMJE November 15, 2005
First Posted Date  ICMJE November 17, 2005
Results First Submitted Date  ICMJE August 23, 2016
Results First Posted Date  ICMJE April 7, 2017
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE May 2005
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2005)
MRS measures of brain NAA and MRI measures of hippocampal volume will serve as the primary outcome measures
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2017)
Mean Change on the ADAS-Cog Score After 1 Year [ Time Frame: Baseline; Year 1 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2005)
Progression as measured by performance on the ADAS-Cog and caregiver and clinician ratings.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients
Official Title  ICMJE The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients: A Randomized, Placebo-Controlled, 52-Week Clinical Trial
Brief Summary 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.
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Memantine
    10mg Memantine
    Other Name: Namenda
  • Drug: Placebo pill
    10mg placebo pill
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Memantine
    10mg Memantine
    Intervention: Drug: Memantine
  • Placebo Comparator: Control
    10 mg Placebo pill
    Intervention: Drug: Placebo pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2010)
17
Original Enrollment  ICMJE
 (submitted: November 15, 2005)
20
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:1. Dementia criteria by DSM-IV.

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.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00255086
Other Study ID Numbers  ICMJE 95722
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jerome A Yesavage,, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • Palo Alto Veterans Institute for Research
  • Forest Laboratories
Investigators  ICMJE
Study Director: J. Wesson Ashford Jr., MD, PhD Stanford University
Principal Investigator: Jerome A Yesavage Stanford University
PRS Account Stanford University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP