Trial · NCT02727699
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ADAS-Cog v14 | Baseline, Week 12 | Change in Alzheimer's Disease Assessment Scales - Cognitive Subscale Score, version 14 (ADAS-Cog v14) Total scores of ADAS Cog 14 range from 0 to 90, with higher scores indicating greater disease severity. |
| Primary | AD COMposite Scores | Baseline, Week 12 | Change in AD COMposite Scores (ADCOMs- ADCOMs, composite score is derived from a weighted linear combination of items from commonly used outcome scales Cognitive Subscale Version 14 \[ADAS-Cog v14\], Clinical Dementia Rating Scale - Sum of Boxes \[CDR-SOB\], and Mini-Mental Status Examination \[MMSE\]. Th ADCOMs range: 0 - 1.97, whereas a lover score is interpreted as a better result. Included scales: ADAS-Cog v14 (range: 0-90): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment. CDR-SOB (range: 0-18): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment. MMSE (range: 0-30): A higher score is indicative of better cognition, a lower score indicates higher cognitive impairment. |
| Secondary | RAVLT | Baseline, Week 12 | Change in Rey Auditory Verbal Learning Test (RAVLT) RAVLT will be administered using five trials, with individual scores from 0-15. The total score is the combined score of all five trials, ranging from 0 to 75, whereas a lower score is considered a worse outcome and a higher score a better outcome. |
| Secondary | CDR-SOB | Baseline, Week 12 | Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB) The CDR is obtained through semi-structured interviews of patients and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB is based on summing each of the domain box scores, with scores ranging from 0-18, whereas lower scores represent better outcomes and higher scores worse outcomes. |
| Secondary | MMSE | Baseline, Week 12 | Change in Mini-Mental Status Examination (MMSE) MMSE total score (0 - 30) is a sum of all 30 point questionnaire of MMSE. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia. |
| Secondary | NPI (Neuropsychiatric Inventory) | Baseline, Week 12 | Change in Neuropsychiatric Inventory (NPI) The NPI includes questions to ten behavioural and two neurodegenerative domains. Raters recorded neuropsychiatric symptoms using a 1-4 scale for frequency and a 1-3 scale for severity for each item in the instrument, with the score for each domain being: domain score = frequency x severity. The total score is calculated by adding the scores of the first 10 domain scores. The two neurodegenerative items are not included in the NPI total score as they form part of the depression syndrome in some patients and were specifically excluded from the dysphoria subscale of the NPI in order to allow that subscale to focus on mood symptoms. The total NPI-score minimum is 0 and the maximum 144. A lower score is considered a better outcome, a higher score a worse outcome. |
| Secondary | NTB - Executive Domain | Baseline, Week 12 | Change in Neuropsychological Test Batteries (NTB) - Executive Domains: Controlled Oral Word Association - Test (COWAT) and Total Correct Response (CFT) Total NTB score is the sum of COWAT and CFT. During the COWAT test, the subject is asked to mention as many words as possible beginning with different letters (F, A, S) within 1 minute each. The number of words for each letter is recorded, the score is the sum of all words. There is no minimum or maximum score, whereas more words indicate a better outcome. During the CFT test, the subject is given 1 minute to produce as many unique words as possible within a semantic category. The subject's score is the number of unique correct words. There is no minimum or maximum score whereas a score of under 14 is interpreted as concerning regarding cognition. |
| Other | Pregnancy Test | Screening, baseline, Week 4, Week, 8, Week 12, Week 16 | Women of childbearing potential only. Serum pregnancy test at screening and a urine pregnancy test at all subsequent clinic visits |
| Other | Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Testosterone | Screening, baseline, Week 4, Week, 8, Week 12, Week 16 | This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit |
| Other | Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Androstenedione | Screening, baseline, Week 4, Week, 8, Week 12, Week 16 | This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit |
| Other | Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Dehydroepiandrosterone Sulfate (DHEAS) | Screening, baseline, Week 4, Week, 8, Week 12, Week 16 | This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit |
| Other | Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Adrenocorticotropic Hormone (ACTH) | Screening, baseline, Week 4, Week, 8, Week 12, Week 16 | This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit |
| Other | Change in Pharmacokinetics (PK), Including Analysis of Cortisol Levels | Baseline, Week 4, Week 8, Week 12 and Unscheduled Safety Visit | This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit |
| Other | NTSS-6 | Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc and Unscheduled Safety Visit | Change in Neuropathy Total Symptom Score (NTSS-6) |
| Other | NFM | Screening, Baseline, Week 4, Week 8, Week 12, Week 16 | Change in Nerve Function Monitoring (NFM) |
| Other | Vital Signs | Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Unscheduled Safety Visit | Change in Vital Signs (including Heart Rate, Blood Pressure, Body Weight, BMI) |
| Other | Metabolic Function | Baseline, Week 12 | Change in Metabolic Function Test Results of Lipids, Glucose, Hemoglobin A1c (HbA1c) |
| Other | Clinical Safety Laboratory Values | Screening, Baseline, Week 4, Week 8, Week 12, Week 16 | Change in Clinical Safety Laboratory Values (biochemistry, hematology, urine examination) |
| Other | AEs | Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc | Incidence of Adverse Events (AEs) |
| Other | ECG | Screening, Baseline, Week 4, Week 8, Week 12, Week 16 | Change in Electrocardiogram (ECG) Values |
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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