Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Memantine; Placebo
Intervention description: One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months; One tablet placebo morning and evening (BID) for 12 months
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Mild Alzheimer's Disease; Driving; Driving Impairment

Summary:

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

Eligibility 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