Trial · NCT02615002
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Computerized Neuropsychological Test Battery (cNTB) Z-Scores - Change From Baseline | 26 weeks | The global composite score of the cNTB combines the International Shopping List Test (ISLT), One Card Learning (OCL), Identification (IDN), Detection (DET), One Back Card (OBK), Controlled Oral Word Association Test (COWAT), and the Categorical Fluency Test (CFT). For each test, a z-score relative to the study baseline is calculated. The cNTB global composite score is the mean of all z-scores from the tests listed above. The scale range is from -3 to 3. Zero Z-score means no cognitive change. A negative value means decline, while a positive value means improvement. |
| Secondary | Change From Baseline in Global Impression of Change (CGIC) | 13 weeks, and 26 weeks | The Change From Baseline in Global Impression of Change (CGIC) rating is made on a 7-point Likert-type scale where the change from baseline is rated as marked improvement (1), moderate improvement (2), minimal improvement (3), no change (4), minimal worsening (5), moderate worsening (6), marked worsening (7). Mean values at 13 and 26 weeks are relative to baseline. |
| Secondary | Alzheimer's Disease Cooperative Study/Activities of Daily Living Scale Adapted for MCI (Mild Cognitive Impairment) Patients (ADCS-MCI-ADL) | Baseline, 13 weeks, and 26 weeks | ADCS-MCI-ADL is an evaluation scale with information provided by an informant/caregiver to describe the functional impairment of patients with mild cognitive impairment (MCI). The ADCS-ADL is a 23-item scale that includes 6 basic ADLs (BADLs) and 17 Instrumental Activities of Daily Living (IADLs) that provide a total score of 0-78, with a lower score indicating greater severity, meaning a worse outcome. |
| Secondary | Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog14) | Baseline, 13 weeks, and 26 weeks | The ADAS was designed to measure the severity of the most important symptoms of AD. Its subscale, ADAS-cog, is the most popular cognitive testing instrument used in clinical trials, measuring the disturbances of memory, language, praxis, attention, and other cognitive abilities that are often referred to as the core symptoms of AD. ADAS-cog14 comprises 14 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. |
| Secondary | Safety and Tolerability - Blood Pressure (mmHg) | Baseline, and 26 weeks | Systolic and Diastolic Blood Pressure is followed during the study, as safety and tolerability measures. Changes in BP following treatment, leading to values out of the normal limits mean a worse outcome. |
| Secondary | Safety and Tolerability - Heart Rate (Bpm) | Baseline, and 26 weeks | Heart Rate within normal limits = 60-100 beats per minute (bpm) during the study means a good outcome in terms of safety. |
| Secondary | Safety and Tolerability - ECG Interval Results - QTcF (Msec) | Baseline, and 26 weeks | QT interval corrected for heart rate by Fridericia's cube root formula (QTcF). The QTc is considered normal at \< 450 msec in males, and \< 470 msec in females. |
| Secondary | Safety and Tolerability - Hematology | Baseline, and 26 weeks | Hematology (GI/L). 1 gill (GI) = 0.118294118 liter (L). No major changes or shifts from baseline mean good safety and tolerability. |
| Secondary | Safety and Tolerability - Blood Chemistry (mmol/L) | Baseline, and 26 weeks | Blood Chemistry follow-up during the experiment. No major changes or shifts from baseline mean good safety and tolerability. |
| Other | NeuroPsychiatric Inventory (NPI) Total Score | Baseline, and 26 weeks | The NPI scale consists of 12 domains that are rated for both frequency (range 1 to 4) and severity (range 1 to 3). A composite score for each domain is calculated (frequency × severity), and it ranges from 1 to 12. For each item, there is a leading question. If the symptom is absent, then the frequency, severity, and distress scores are not completed. In this case, the score is 0 for the item. The sum of the composite scores yields the NPI total score (1-12). A negative change in the score indicates an improvement from baseline (symptom reduction). |
| Other | Pittsburgh Sleep Quality Index (PSQI) - Global Component Score | Baseline, 4 weeks, 13 weeks, 26 weeks | PSQI is an effective instrument used to measure the quality and patterns of sleep in older adults. It differentiates "poor" from "good" sleep by measuring 7 areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. PSQI includes seven components, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02615002/registered