Trial · NCT00550459
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores) | baseline and Day 22 | Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize "yes" 50 times;Choice=recognize "yes" or "no" 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right \& left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data |
| Secondary | Change From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Tests | baseline and Day 22 | Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population |
| Secondary | Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Test | baseline and Day 22 | Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population |
| Secondary | Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test | baseline and Day 22 | Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population |
| Secondary | Change From Baseline in Overall Neurocognitive Composite Score | baseline and Day 22 | Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population |
| Secondary | Change From Baseline in Gait Test (Timed Get-Up-and-Go Test) | baseline and Day 22 | Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population |
| Secondary | Change From Baseline in Postural Stability Test | baseline and Day 22 | Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population |
| Secondary | Change From Baseline in Serum Sodium; ITT Population | Baseline and Day 22 | Change from Baseline to Day 22 in Serum Sodium; ITT population |
| Secondary | Number of Patients With Vital Sign Abnormalities: Blood Pressure | 28 days | Incidence of abnormal systolic \& diastolic blood pressure values post-baseline (abnormal systolic values: \>=180 mmHg + increase of \>=20 mmHg, \<= 90 mmHg + decrease \>=20 mmHg; abnormal diastolic values: \>=105 mmHg+increase of \>=15 mmHg, \<=50 mmHg + decrease of \>= 15 mmHg) |
| Secondary | Number of Patients With Vital Sign Abnormalities: Pulse Rate | 28 days | Incidence of abnormal pulse rate post-baseline \[abnormal values: \>=120 beats per minute (bpm) + increase of \>=15 bpm; \<=50 bpm + decrease of \>=15 bpm\] |
| Secondary | Number of Patients With Vital Sign Abnormalities: Body Weight | 28 days | Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of \>=7%) |
| Secondary | Number of Patients With Vital Sign Abnormalities: Body Temperature | 28 days | Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of \>=1.1 to \>=38.3 degrees Celsius) |
| Secondary | Number of Patients With Hematology Laboratory Abnormalities: Hemoglobin | 28 days | Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8 g/dL) |
| Secondary | Number of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT) | 28 days | Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds) |
| Secondary | Number of Patients With Hematology Laboratory Abnormalities: Lymphocytes | 28 days | Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%) |
| Secondary | Number of Patients With Hematology Laboratory Abnormalities: Neutrophils | 28 days | Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8 thousands/microliter) |
| Secondary | Number of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN) | 28 days | Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL) |
| Secondary | Number of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid | 28 days | Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5 mg/dL) |
| Secondary | Number of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol | 28 days | Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL) |
| Secondary | Number of Patients With Serum Chemistry Laboratory Abnormalities: Glucose | 28 days | Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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