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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Memantine

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Mild Alzheimer's Disease, Driving, Driving Impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charles E. Schmidt College of Medicine, Florida Atlantic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Memantine

Arm Description

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

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

Outcomes

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).

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.

Secondary Outcome Measures

Fuld Object Memory Evaluation

Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity. Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment.

Rey Complex Figure Test

This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment

Trail Making Test - Part A

A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning.

Trail Making Test - Part B

This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning.

Mini Mental Status Exam

Scores range from 0-30 with lower scores indicating decreased functioning.

Useful Field of View

The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment.

Motor Free Visual Perception Test - Visual Closure Subtest

This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment.

Cognitive Dementia Rating Scale

This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe.

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment.

Full Information

NCT ID

NCT00476008

First Posted

May 17, 2007

Last Updated

August 7, 2014

Sponsor

Florida Atlantic University

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00476008

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Florida Atlantic University

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

It is well known, and of great concern to both patients and families, that individuals with Alzheimer's disease (AD) 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Memantine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Memantine

Other Intervention Name(s)

Namenda

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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).

Description

Time Frame

Baseline and 12 months

Secondary Outcome Measure Information:

Title

Fuld Object Memory Evaluation

Description

Time Frame

baseline and 12 months

Title

Rey Complex Figure Test

Description

Time Frame

baseline and 12 months

Title

Trail Making Test - Part A

Description

A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning.

Time Frame

baseline and 12 months

Title

Trail Making Test - Part B

Description

Time Frame

baseline and 12 months

Title

Mini Mental Status Exam

Description

Scores range from 0-30 with lower scores indicating decreased functioning.

Time Frame

baseline and 12 months

Title

Useful Field of View

Description

Time Frame

baseline and 12 months

Title

Motor Free Visual Perception Test - Visual Closure Subtest

Description

Time Frame

baseline and 12 months

Title

Cognitive Dementia Rating Scale

Description

This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe.

Time Frame

baseline and 12 months

Title

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)

Description

Time Frame

baseline and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter J Holland, MD

Organizational Affiliation

Charles E, Schmidt College of Medicine at Florida Atlantic University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charles E. Schmidt College of Medicine, Florida Atlantic University

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33431

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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