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CompletedPhase 4Results posted

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

Asset

Memantine

Listed sites

1

Recruiting sites

-

Enrollment

60

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≥23

Primary endpoint

•Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDNAM-MD-49
NCT IDNCT00476008

Timeline

Milestones

Study first posted2007-05-21estimated
Study start2007-07 (month precision)
Primary completion2012-10actual (month precision)
Study completion2012-10actual (month precision)
Results first posted2014-06-03estimated
Last update posted2014-08-11estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
8
Executive function / language
6
Global cognition
4
Memory
2

Global cognition

4 endpoints
Secondary/protocol endpoint

Mini Mental Status Exam

Time frame:baseline and 12 months

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Secondary/protocol endpoint

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

Time frame:baseline and 12 months

ADAS-Cog

descriptive

Secondary/registry result

Mini Mental Status Exam

Time frame:baseline and 12 months

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
PlaceboBaselinen=13 Participants27.671.63
12 Monthsn=13 Participants26.003.56
MemantineBaselinen=13 Participants28.132.00
12 Monthsn=13 Participants27.152.34
Secondary/registry result

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

Time frame:baseline and 12 months

ADAS-Cog

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Placebo1) Word Recall - Baselinen=13 Participants4.331.28
1) Word Recall - 12 Monthsn=13 Participants4.561.97
2) Commands - Baselinen=13 Participants.40.51
2) Commands - 12 Monthsn=13 Participants.23.60
3) Constructional Praxis - Baselinen=13 Participants3.40.51
3) Constructional Praxis - 12 Monthsn=13 Participants3.54.52
4) Ideational Praxis - Baselinen=13 Participants5.000
4) Ideational Praxis - 12 monthsn=13 Participants4.92.28
5) Naming - Baselinen=13 Participants1.801.70
5) Naming - 12 monthsn=13 Participants1.311.38
6) Orientation - Baselinen=13 Participants.801.01
6) Orientation - 12 Monthsn=13 Participants.851.34
7) Word Recognition - Baselinen=13 Participants9.606.07
7) Word Recognition - 12 Monthsn=13 Participants8.108.39
8) Remember Test Instructions - Baselinen=13 Participants0.000
8) Remember Test Instructions - 12 Monthsn=13 Participants0.000
9) Spoken Language - Baselinen=13 Participants.20.77
9) Spoken Language - 12 Monthsn=13 Participants.23.83
10) Word Finding - Baselinen=13 Participants.13.52
10) Word Finding - 12 Monthsn=13 Participants.15.55
11) Comprehension - Baselinen=13 Participants.07.26
11) Comprehension - 12 Monthsn=13 Participants.31.63
Memantine1) Word Recall - Baselinen=13 Participants4.001.26
1) Word Recall - 12 Monthsn=13 Participants4.131.31
2) Commands - Baselinen=13 Participants00
2) Commands - 12 Monthsn=13 Participants.852.76
3) Constructional Praxis - Baselinen=13 Participants3.44.63
3) Constructional Praxis - 12 Monthsn=13 Participants3.46.52
4) Ideational Praxis - Baselinen=13 Participants5.000
4) Ideational Praxis - 12 monthsn=13 Participants5.000
5) Naming - Baselinen=13 Participants2.383.93
5) Naming - 12 monthsn=13 Participants1.771.69
6) Orientation - Baselinen=13 Participants.441.09
6) Orientation - 12 Monthsn=13 Participants.46.88
7) Word Recognition - Baselinen=13 Participants7.275.42
7) Word Recognition - 12 Monthsn=13 Participants9.314.91
8) Remember Test Instructions - Baselinen=13 Participants0.000
8) Remember Test Instructions - 12 Monthsn=13 Participants0.000
9) Spoken Language - Baselinen=13 Participants0.000
9) Spoken Language - 12 Monthsn=13 Participants01.00
10) Word Finding - Baselinen=13 Participants0.000
10) Word Finding - 12 Monthsn=13 Participants.08.28
11) Comprehension - Baselinen=13 Participants.06.25
11) Comprehension - 12 Monthsn=13 Participants.15.38

Memory

2 endpoints
Secondary/protocol endpoint

Fuld Object Memory Evaluation

Time frame:baseline and 12 months

event count, event

Secondary/registry result

Fuld Object Memory Evaluation

Time frame:baseline and 12 months

event count, event

Posted result

GroupValue (mean), units on a scaleStandard deviation
PlaceboBaseline Sum of Retrieval Scoren=13 Participants18.875.00
12 month Sum of Retrieval Scoren=13 Participants19.088.47
MemantineBaseline Sum of Retrieval Scoren=13 Participants18.388.76
12 month Sum of Retrieval Scoren=13 Participants17.945.85

Executive function / language

6 endpoints
Secondary/protocol endpoint

Trail Making Test - Part A

Time frame:baseline and 12 months

descriptive

Secondary/protocol endpoint

Trail Making Test - Part B

Time frame:baseline and 12 months

descriptive

Secondary/protocol endpoint

Useful Field of View

Time frame:baseline and 12 months

descriptive

Secondary/registry result

Trail Making Test - Part A

Time frame:baseline and 12 months

descriptive

Posted result

GroupValue (mean), secondsStandard deviation
PlaceboBaselinen=13 Participants50.3317.2
12 monthsn=13 Participants53.4622.00
MemantineBaselinen=13 Participants39.6312.37
12 monthsn=13 Participants38.5416.32
Secondary/registry result

Trail Making Test - Part B

Time frame:baseline and 12 months

descriptive

Posted result

GroupValue (mean), secondsStandard deviation
PlaceboBaselinen=13 Participants195.33128.58
12 monthsn=13 Participants233.15159.49
MemantineBaselinen=13 Participants117.7543.03
12 monthsn=13 Participants170.92145.33
Secondary/registry result

Useful Field of View

Time frame:baseline and 12 months

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
PlaceboBaselinen=13 Participants3.001.31
12 monthsn=13 Participants2.541.45
MemantineBaselinen=13 Participants2.441.50
12 monthsn=13 Participants2.081.38

Other (unclassified)

8 endpoints
Primary/protocol endpoint/low confidence

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

event count, event

Primary/registry result/low confidence

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

event count, event

Posted result

GroupValue (number), participantsReported spread
MemantineDriveABLE passedn=13 Participants130
DriveABLE same or improvedn=13 Participants13-
PlaceboDriveABLE passedn=12 Participants10-
DriveABLE same or improvedn=12 Participants9-
Secondary/protocol endpoint/low confidence

Rey Complex Figure Test

Time frame:baseline and 12 months

descriptive

Secondary/protocol endpoint/low confidence

Motor Free Visual Perception Test - Visual Closure Subtest

Time frame:baseline and 12 months

descriptive

Secondary/protocol endpoint/low confidence

Cognitive Dementia Rating Scale

Time frame:baseline and 12 months

categorical status, descriptive

Secondary/registry result/low confidence

Rey Complex Figure Test

Time frame:baseline and 12 months

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
PlaceboBaselinen=13 Participants27.536.05
12 Monthsn=13 Participants29.964.54
MemantineBaselinen=13 Participants29.305.10
12 Monthsn=13 Participants27.855.75
Secondary/registry result/low confidence

Motor Free Visual Perception Test - Visual Closure Subtest

Time frame:baseline and 12 months

descriptive

Posted result

GroupValue (mean), number incorrectStandard deviation
PlaceboBaselinen=13 Participants2.932.52
12 monthsn=13 Participants3.232.83
MemantineBaselinen=13 Participants2.002.19
12 monthsn=13 Participants2.692.53
Secondary/registry result/low confidence

Cognitive Dementia Rating Scale

Time frame:baseline and 12 months

categorical status, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
PlaceboBaselinen=13 Participants2.301.31
12 Monthsn=13 Participants2.312.71
MemantineBaselinen=13 Participants2.411.11
12 Monthsn=13 Participants1.811.61

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.