Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease

NCT00476008 | Completed Phase 4 Results

• 1 other identifier: NAM-MD-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles.

  Baseline and 12 months

Secondary Outcomes (9)

• Fuld Object Memory Evaluation

  baseline and 12 months

• Rey Complex Figure Test

  baseline and 12 months

• Trail Making Test - Part A

  baseline and 12 months

• Trail Making Test - Part B

  baseline and 12 months

• Mini Mental Status Exam

  baseline and 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One tablet placebo morning and evening (BID) for 12 months

Drug: Placebo

Memantine

ACTIVE COMPARATOR

One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months.

Drug: Memantine

Interventions

Memantine DRUG

One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months

Also known as: Namenda

Memantine

Placebo DRUG

One tablet placebo morning and evening (BID) for 12 months

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Atlantic University: lead
• Forest Laboratories: collaborator

Study Sites (1)

Charles E. Schmidt College of Medicine, Florida Atlantic University

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Peter Holland, MD
• Organization: Charles E. Schmidt College of Medicine, Florida Atlantic University

holland@fau.edu

561-297-0164

Study Officials

• Peter J Holland, MD

  Charles E, Schmidt College of Medicine at Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 11, 2014
• Results First Posted: June 3, 2014

Record last verified: 2014-08

Locations

US (1)