Phase 4
Completed N=43
Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease
Source: ClinicalTrials.gov NCT00476008 ↗Enrolled (actual)
43
Serious AEs
11.6%
Results posted
Jun 2014
Primary outcomePrimary: 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). — 13; 10; 13; 9 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
13; 10; 13; 9 | — |
| SECONDARY Fuld Object Memory Evaluation |
18.87; 18.38; 19.08; 17.94 | — |
| SECONDARY Rey Complex Figure Test |
27.53; 29.30; 29.96; 27.85 | — |
| SECONDARY Trail Making Test - Part A |
50.33; 39.63; 53.46; 38.54 | — |
| SECONDARY Trail Making Test - Part B |
195.33; 117.75; 233.15; 170.92 | — |
| SECONDARY Mini Mental Status Exam |
27.67; 28.13; 26.00; 27.15 | — |
| SECONDARY Useful Field of View |
3.00; 2.44; 2.54; 2.08 | — |
| SECONDARY Motor Free Visual Perception Test - Visual Closure Subtest |
2.93; 2.00; 3.23; 2.69 | — |
| SECONDARY Cognitive Dementia Rating Scale |
2.30; 2.41; 2.31; 1.81 | — |
| SECONDARY Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) |
4.33; 4.00; 4.56; 4.13; .40; 0 | — |
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 ( 3 months prior to baseline. No initiation of AChEls is permitted; discontinuation and dose reduction are permitted
Data sourced from ClinicalTrials.gov (NCT00476008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.