Alzheimer's DiseasePhase 4NCT00476008
Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease
A Phase 4 study testing Memantine in people with Alzheimer's Disease, run by Florida Atlantic University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles E. Schmidt College of Medicine, Florida Atlantic University
Boca Raton, Florida, 33431
About this study
The purpose of the study is to determine whether memantine delays the progression of driving impairment in patients with mild Alzheimer's Disease (AD).
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Memantine, Placebo
- Keywords
- Alzheimer's Disease, Mild Alzheimer's Disease, Driving, Driving Impairment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Namenda
One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
PlaceboDrug
One tablet placebo morning and evening (BID) for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One tablet placebo morning and evening (BID) for 12 months Receives: Drug: Placebo |
| Memantine | Active comparator | One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months. Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (9)
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.
Measured: baseline and 12 months
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
Measured: baseline and 12 months
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.
Measured: baseline and 12 months
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.
Measured: baseline and 12 months
Mini Mental Status Exam
Scores range from 0-30 with lower scores indicating decreased functioning.
Measured: baseline and 12 months
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.
Measured: baseline and 12 months
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.
Measured: baseline and 12 months
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.
Measured: baseline and 12 months
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.
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startJul 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Atlantic University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Peter J Holland, MD, Principal investigator, Charles E, Schmidt College of Medicine at Florida Atlantic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476008
- Sponsor's protocol ID
- NAM-MD-49
- Status last verified
- Aug 2014
- First submitted
- 17 May 2007
- Last updated
- 11 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00476008
- Acronym / sponsor ID
- NAM-MD-49
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Mild Alzheimer's Disease, Driving, Driving Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Florida Atlantic UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jul 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOne tablet placebo morning and evening (BID) for 12 months |
| Memantine | Active comparator | Drug: MemantineOne tablet memantine (Namenda)10mg morning and evening (BID) for 12 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: NamendaOne tablet memantine (Namenda)10mg morning and evening (BID) for 12 months | Drug | Memantine |
| PlaceboOne tablet placebo morning and evening (BID) for 12 months | Drug | Placebo |
Primary outcome
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: Baseline and 12 months
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.
9 secondary outcomes
Fuld Object Memory Evaluation
Time frame: baseline and 12 months
Rey Complex Figure Test
Time frame: baseline and 12 months
Trail Making Test - Part A
Time frame: baseline and 12 months
Trail Making Test - Part B
Time frame: baseline and 12 months
Mini Mental Status Exam
Time frame: baseline and 12 months
Useful Field of View
Time frame: baseline and 12 months
Motor Free Visual Perception Test - Visual Closure Subtest
Time frame: baseline and 12 months
Cognitive Dementia Rating Scale
Time frame: baseline and 12 months
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time frame: baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Holland, MD principal investigator
Charles E, Schmidt College of Medicine at Florida Atlantic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine in people with Alzheimer's Disease, run by Florida Atlantic University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2014.