NCT00255086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_3 alzheimer-disease

Timeline
Completed

Started May 2005

Longer than P75 for phase_3 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

April 7, 2017

Completed
Last Updated

April 7, 2017

Status Verified

February 1, 2017

Enrollment Period

4.1 years

First QC Date

November 15, 2005

Results QC Date

August 23, 2016

Last Update Submit

February 23, 2017

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline; Year 1

Secondary Outcomes (1)

  • Mean Change on the ADAS-Cog Score After 1 Year

    Baseline; Year 1

Study Arms (2)

Memantine

EXPERIMENTAL

10mg Memantine

Drug: Memantine

Control

PLACEBO COMPARATOR

10 mg Placebo pill

Drug: Placebo pill

Interventions

MemantineDRUG

10mg Memantine

Also known as: Namenda
Memantine
Placebo pillDRUG

10mg placebo pill

Also known as: placebo
Control

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 50-95 years of age inclusive.
  • \. MMSE at screen and baseline 7-28 inclusive.
  • \. Conversant in English.
  • \. Caregiver/study partner willing to participate, supervise the patient and be available for administration of study medication.

You may not qualify if:

  • \. Neurological or medical conditions causing significant disability independent of dementia.
  • \. Parkinson's disease.
  • \. 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.
  • \. Dementia due to Korsakoff's syndrome or infectious diseases such as Creutzfeldt-Jakob disease, herpes, encephalitis, or human immunodeficiency virus.
  • \. Sensory impairment that would prevent subject from participating in or cooperating with the protocol.
  • \. 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.
  • \. Clinical contraindication to the use of memantine (e.g., hypersensitivity).
  • \. History of seizure within past 5 years prior to screening.
  • \. Platelet count \< 100,000/mm3.
  • \. History of claustrophobia
  • \. Presence of metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Wes Ashford, PhD, MD
Organization
VA Palo Alto Health Care System
wes.ashford@va.gov
650-493-5000

Study Officials

  • J. Wesson Ashford Jr., MD, PhD

    Stanford University

    STUDY DIRECTOR

  • Jerome A Yesavage

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 15, 2005

First Posted

November 17, 2005

Study Start

May 1, 2005

Primary Completion

June 1, 2009

Study Completion

February 1, 2010

Last Updated

April 7, 2017

Results First Posted

April 7, 2017

Record last verified: 2017-02

Locations

US(1)