The Mini-Mental State Examination is still the most common cognitive entry criterion in dementia trials. Capture the section scores and total in a structured form, with range checks and the attention task used recorded at every visit.
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Orientation to time (0 to 5)
Orientation to place (0 to 5)
Attention task used
Attention and calculation (0 to 5)
Total score (0 to 30)
Below protocol range 20 to 26
MMSE at a glance
The instrument
Half a century after publication, the MMSE remains the reference point that clinicians, ethics committees and regulators recognise for overall cognitive severity. Its familiarity is its main advantage in trials: an MMSE range in the inclusion criteria tells everyone roughly which stage of disease the study enrols, and results can be compared with decades of published data.
Its limitations are equally well known. It has ceiling effects in people with high education and mild impairment, it is less sensitive to executive dysfunction than the MoCA, and it changes too slowly to serve as a primary efficacy endpoint in most modern trials. That is why it tends to appear at screening and as a secondary or staging measure, with longer scales such as the ADAS-Cog carrying efficacy.
Each section score is added to give a total of 0 to 30; lower means more impairment. Because education, age and language all affect scores, some studies apply adjusted cut-offs. Write the exact eligibility range and any adjustment into the protocol and use the same rule at every site.
The attention and calculation item can be administered as serial subtraction of seven from 100 or as spelling WORLD backwards. The two are not interchangeable in difficulty, so studies should specify which is used and the eCRF should record it at each administration.
Screening total
19 / 30
Structure
| Section | Max points | eCRF field |
|---|---|---|
| Orientation to time | 5 | Number, 0 to 5 |
| Orientation to place | 5 | Number, 0 to 5 |
| Registration (three words) | 3 | Number, 0 to 3 |
| Attention and calculation | 5 | Number, 0 to 5, plus task used |
| Recall (three words) | 3 | Number, 0 to 3 |
| Naming | 2 | Number, 0 to 2 |
| Repetition | 1 | Number, 0 to 1 |
| Three-stage command | 3 | Number, 0 to 3 |
| Reading | 1 | Number, 0 to 1 |
| Writing | 1 | Number, 0 to 1 |
| Copying (intersecting pentagons) | 1 | Number, 0 to 1 |
| Total | 30 | Number, 0 to 30, with eligibility range check |
Structure only. Obtain the official MMSE forms and licence from the rights holder.
Eligibility
Put the protocol range on the total as a range edit check. A total outside the range raises an auto-query straight away, so the site either confirms the participant is ineligible or catches an arithmetic mistake before the screening visit ends. The eligibility form then records the criterion as met or not met.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Licensing
Because the MMSE is licensed, record the licence details on the form in Capture: licence number, holder and expiry. The form carries a staff-only watermark until the licence is recorded, and new data collection stops if it lapses.
Copyright & licence
Approval pendingLicence number
Not recorded
Expiry date
Not recorded
Watermark shown to staff only. Participants never see it.
Build the sections, set your protocol range and enter a sample total below it.
Before go-live
Record licence details on the form in Capture.
Serial sevens or WORLD, the same for everyone, recorded each time.
Range check matching the inclusion criterion exactly.
Standardise administration and scoring across sites before first participant.
The completed test sheet is the source; the eCRF records scores.
Verify the total and the sections most prone to scoring error.
In dementia trials
In most Alzheimer's disease programs the MMSE does three jobs. At screening it defines the disease stage the trial enrols, usually as a range of total scores in the inclusion criteria. During the study it can describe how the population progresses, as a secondary or supportive measure. And across a program it gives a common language for comparing populations between trials.
Its practice effects are smaller than those of word-list-heavy tests, but repeated administration still produces some learning, particularly in people with mild impairment. Studies that give the MMSE often should keep the interval consistent and record any deviation from standard administration.
Participants near the boundary of an eligibility range may score in range on one day and out of range on another. If the protocol allows rescreening, record the first attempt as a screen failure and the rescreen as a new screening, as the eligibility screening template does, so the history is visible.
Eleven section scores are summed for a total of 0 to 30. Lower scores mean more cognitive impairment.
One commonly used convention is 24 to 30 no significant impairment, 18 to 23 mild and 0 to 17 severe, but cut-offs vary and are affected by age and education. Trials define their own ranges in the protocol.
No. It is copyrighted and licensed. Obtain official forms and permission from the rights holder.
Either is acceptable, but they are not equivalent in difficulty. Pick one, write it into the protocol and record it on the eCRF.
Yes. A range edit check on the total raises an auto-query when the score is outside the protocol range.
The MoCA is more sensitive to mild cognitive impairment; the MMSE has a longer history in Alzheimer's disease trials. Many programs use one for eligibility and a longer scale for efficacy.
Keep exploring
MoCA eCRF template
More sensitive to mild impairment.
ADAS-Cog eCRF template
Cognitive efficacy in Alzheimer's trials.
EDC for Alzheimer's trials
Cognitive, functional and caregiver outcomes.
Eligibility screening template
Where the MMSE range is confirmed.
Edit checks software
Range checks and auto-queries.
eCRF software
Data entry, SDV and locking.
Build an MMSE form with a protocol range check in minutes. Free sandbox.