Dementia trials involve two people per participant, long follow-up and consent that may need a legally authorised representative. Capture handles cognitive scales, caregiver reports, representative signatures and safety imaging in one study.
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| Assessment | Scr | BL | M3 | M6 | M9 | M12 | M18 |
|---|---|---|---|---|---|---|---|
| MMSE | |||||||
| CDR-SB | |||||||
| ADAS-Cog 13 | |||||||
| ADL (study partner) | |||||||
| Safety MRI | |||||||
| Amyloid biomarker |
What matters in Alzheimer's trials
Endpoints
Alzheimer's disease progresses over years, and treatments aim to slow that progression. Trials therefore measure decline, not improvement, across 18 months or more, and the treatment effect is the difference in how fast the arms decline. Small measurement errors accumulate over that time, so consistency of administration is critical.
Recent disease-modifying trials have used composite or global measures such as the Clinical Dementia Rating Sum of Boxes (CDR-SB, 0 to 18), which combines cognitive and functional information from an interview with the participant and their study partner. Cognitive tests such as the ADAS-Cog and functional scales completed with the study partner sit alongside it.
A participant seen by different raters at baseline and month 18 picks up the difference between raters as apparent change. Capture attributes every value to the person who entered it, so rater changes are visible per participant before analysis. Range checks on each item and task catch scoring errors at entry.
Many dementia scales are copyrighted. Record licence number, holder and expiry on each form; until a licence is recorded the form carries a staff-only watermark, and if it lapses new data collection stops rather than continuing out of compliance.
Copyright & licence
Approval pendingLicence number
Not recorded
Expiry date
Not recorded
Watermark shown to staff only. Participants never see it.
Study partners
Activity of daily living scales and behavioural symptom inventories are completed by the study partner, not the participant. In Capture an assessment can be set to be completed by a caregiver, as an observer-reported outcome, on their own phone or at the site visit. Their answers sit in the participant's record without mixing with the participant's own reports.
Patient-reported
Participant, own phone
Observer-reported
Caregiver
Clinician-reported
Site staff, clinic tablet
Performance outcome
Site-run test, e.g. chair rise
Consent and capacity
Participants with early Alzheimer's disease can often consent for themselves at the start, but capacity may change during a long study. Capture's eConsent supports a legally authorised representative signature and an optional witness co-signature, alongside the investigator countersignature. Each signature is cryptographically linked to the exact document signed.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Biomarkers and safety imaging
Amyloid confirmation at screening and scheduled MRI scans for amyloid-related imaging abnormalities (ARIA) are central to anti-amyloid therapy trials. Record biomarker results and central MRI reads on structured forms placed on the schedule, so eligibility and dosing decisions reference the same data, and route significant findings into the adverse event workflow.
SAE timeline
SAE reported
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
AE sign-off (PI / Sub-I)
Awaiting signature
Build cognition, partner reports and safety imaging on one schedule in the free sandbox.
Retention
Dropout in long dementia trials is driven as much by the burden on the study partner as by the participant. Every visit asks a family member to take time off, travel and answer questionnaires. Anything that reduces that burden helps retention and protects the endpoint from missing data.
Letting partners complete their questionnaires at home on their own phone, between visits, removes part of the visit. Clear visit windows and reminders reduce missed assessments. And a dashboard that shows which participants are falling behind gives sites time to intervene before a participant is lost. For more on remote options, see hybrid clinical trial software.
Screening
Disease-modifying Alzheimer's trials screen many more people than they enrol. Candidates must pass cognitive thresholds, a biomarker test confirming amyloid pathology, MRI safety criteria and often genetic testing, each of which removes a share of the pool. Every screen failure costs site time and participant goodwill, so understanding where people drop out is as important as recruiting them.
Record each screening step as structured data with a coded reason when a participant fails, rather than a free-text note. That lets the sponsor see, by site and over time, whether candidates are failing on cognition, biomarkers or imaging, and adjust pre-screening accordingly. Capture's screening wizard issues screening numbers, handles rescreening as a separate record, and the eligibility screening template captures criterion-level results with investigator sign-off.
Short online questionnaires can identify likely candidates before a full screening visit, reducing the number of people who travel for assessments they will fail. See clinical trial pre-screening tools for how that works, and the pre-screening consent template for the consent it needs.
Study build
Cognitive, global and functional measures with versions, licences and rater requirements.
Caregiver-completed assessments set up with their own schedule.
Participant, LAR and witness signatures configured for your population.
Cognition, biomarker and imaging results with coded screen-failure reasons.
MRI visits and read forms tied to dosing visits.
Remote options for partners, reminders and dashboard review of at-risk participants.
Item-level capture of cognitive and functional scales, caregiver-completed forms, consent with representative signatures, biomarker and imaging forms, and long schedules with visit windows.
Yes. Assessments can be set to be completed by a caregiver, on their own phone or at the site.
Yes. eConsent supports LAR signatures and optional witness co-signatures, with investigator countersignature.
Licence details are recorded on each form, and data collection is blocked if the licence lapses.
Yes. MRI reads can be recorded on structured forms at scheduled visits, with checks that flag findings needing review and routing into the AE workflow.
Yes. The free sandbox has every feature with no credit card.
Keep exploring
Partner reports, representative consent and long schedules. Free sandbox.