Trial · NCT02361424
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the total score of the 11-item Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog) | Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) | Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater cognitive impairment. |
| Primary | Number of Treatment Emergent Adverse Events (TEAEs) | throughout the 12-week study period. | |
| Secondary | Change From Baseline in the score of the Digit Symbol Substitution Test (DSST) | Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) | Scores on the DSST range from 0-93 with lower scores indicating greater impairment. |
| Secondary | Change From Baseline in the speed to perform the Zazzo's Cancellation Test | Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) | |
| Secondary | Change From Baseline in the score of the Zazzo's Cancellation Test | Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) | |
| Secondary | Change From Baseline in the score of the 15-second Isaacs Set Test | Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) | |
| Secondary | Change From Baseline in the time score of the Trail Making Test - part A | Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) | |
| Secondary | Change From Baseline in the time score of the Trail Making Test - part B | Visit V0 (train), V1 (baseline), and every 4 weeks (visits V2, V3 and V4) | |
| Secondary | Change From Baseline in the score of the Free and Cued Selective Reminding Test (FCSRT) | 1 (baseline) and V4 (end of study, after 12 weeks of treatment) | FCSRT is a memory test administered according to the procedure described by Gröber and Buschke modified with 16 verbal items. |
| Secondary | Change From Baseline in the score of the 4-item Instrumental Activities of Daily Living scale (IADL-PAQUID) | V0 (train), V1 (baseline), and every 4 weeks (V2, V3 and V4) | The 4-item Instrumental Activities of Daily Living scale (IADL) concerns four routine daily functions (using transportation, managing finances, using the phone and managing medicines use). Scores on the IADL range from 4-15 with higher scores indicating greater impairment. |
| Secondary | Change From Baseline in the score of the Clinical Dementia Rating (CDR) scale | 1 (baseline) and V4 (end of study, after 12 weeks of treatment) | The Sum of Boxes score of the CDR ranges from 0 to 18, with higher scores indicating greater impairment. |
| Secondary | Change From Baseline in the score of the Apathy Inventory (AI) scale | 1 (baseline) and V4 (end of study, after 12 weeks of treatment) | Scores on the AI range from 0-12 with higher scores indicating greater impairment. |
| Other | Change From Baseline in the cognitive Event Related Potential parameters (optional) | V1 (baseline), and every 4 weeks (V2, V3 and V4) | Some cognitive Event Related Potentials (ERP) with auditory oddball paradigm are performed as an ancillary study. |
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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GET https://conductscience.org/api/trials/v1/NCT02361424/registered