Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease - Full Text View

Sponsor:	Florida Atlantic University
Collaborator:	Forest Laboratories
Information provided by (Responsible Party):	Florida Atlantic University
ClinicalTrials.gov Identifier:	NCT00476008

Purpose

The purpose of the study is to determine whether memantine delays the progression of driving impairment in patients with mild Alzheimer's Disease (AD).

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Memantine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Further study details as provided by Florida Atlantic University:

Primary Outcome Measures:

The primary outcome measure is the number of subjects in each group who are able to pass the DriveABLE-On Road Test at Month 12 (endpoint). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome measures are the change from Baseline to End Point on driving-related measures; DriveABLE-On Road Test, ADAS-cog, FULD, Rey-Osterrieth Complex Figure Test, Trail Making Test, Useful Field of View, Motor Free Visual Perception Test. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo Placebo BID for 12 months
Active Comparator: Memantine	Drug: Memantine Memantine (Namenda)10mg BID for 12 months Other Name: Namenda

Detailed Description:

It is well known, and of great concern to both patients and families, that individuals with Alzheimer's disease eventually become driving impaired. Drivers with dementia are estimated to be 2-8 times more likely to be involved in an automobile crash as unimpaired peers. Approximately half of individuals with mild AD have the skills needed to drive safely. Formal driver evaluation may be necessary to make this distinction. Some reviews in the literature have suggested that individuals identified as high risk, such as those with AD, be advised by their physicians to cease driving altogether. Other studies suggest that these individuals may continue to drive for up to 4 years following diagnosis. Memantine may be effective in delaying the progression of driving impairment in individuals with mild Alzheimer's Disease (AD). If the investigators can demonstrate a significant delay in the decline in the driving ability, this could extend their driving time and therefore be of immense benefit to patients and their caregivers.

Comparison(s): Subjects treated with memantine over a period of 12 months, compared to subjects on placebo.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women ages 60 years of age and older
Subjects must either be previously diagnosed with mild Alzheimer's Disease (AD) by a neurologist, psychiatrist, geriatrician, or be evaluated at a Memory Disorders Center prior to entry into the study
Subjects must have a score of ≥ 23 on the Mini-Mental State Examination (MMSE) at the Screening Visit
Subjects must receive a passing score on the DriveABLE test
Female subjects must be at least 2 years post-menopausal or surgically sterile
Written informed consent must be obtained from the subject prior to the initiation of any study specific procedures

Exclusion Criteria:

Subjects who have been treated with a depot neuroleptic within six (6) months of the Screening Visit
Subjects who fail the OPTEC vision test at the screening visit
Subjects who score > 7 on the Hachinski Test at the screening visit
Subjects with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease (subjects with controlled hypertension, right bundle branch block [complete or partial] and pacemakers may be included in the study). Subjects with thyroid disease may also be included in the study, provided they are euthyroid on treatment. Subjects with controlled diabetes may also be included
Recent (< 2years) B12 or folate deficiency that was considered clinically significant
Subjects with evidence of other psychiatric/neurologic disorders including, but not limited to, stroke, Vascular Dementia, Lewy-Body Disease, Parkinson's Disease, seizure disorder, head injury with loss of consciousness within the past 5 years, any psychotic disorder, or bipolar disorder
Subjects who are taking, or have taken, amantadine, ketamine, dextromethorphan that cannot be discontinued or switched to an allowable alternative medication prior to the minimum allowable interval before Baseline
Subjects who have been in an investigational drug study or who have received treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit
Any condition, which would make the subject, in the opinion of the investigator, unsuitable for the study
If subjects are taking Acetylcholinesterase inhibitors (AChEls), they must be on a stable dose for > 3 months prior to baseline. No initiation of AChEls is permitted; discontinuation and dose reduction are permitted

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476008

Locations

United States, Florida
Clinical Research Studies at Florida Atlantic University
Boca Raton, Florida, United States, 33431

Sponsors and Collaborators

Florida Atlantic University

Forest Laboratories

Investigators

Principal Investigator:

Peter J Holland, MD

College of Medicine at Florida Atlantic University

More Information

No publications provided

Responsible Party:	Florida Atlantic University
ClinicalTrials.gov Identifier:	NCT00476008 History of Changes
Other Study ID Numbers:	NAM-MD-49
Study First Received:	May 17, 2007
Last Updated:	November 23, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Florida Atlantic University:

Alzheimer's Disease
Mild Alzheimer's Disease
Driving
Driving Impairment

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012