FDA-cleared · interpreted by qualified professionals

Serial cognitive measurement for memory concerns.

Cognitive impairment is common, under-detected, and easiest to act on early. DANA gives primary care, neurology, and senior-care teams a fast, objective way to establish a baseline and track change over time — the signal that matters when following a memory concern. It is not a diagnostic tool.

  • 5-minute assessment
  • Individual baselines
  • Works offline
  • iOS & Android
  • Supports the AWV
Subject · Illustrative Cognition vs. individual baseline
Tracking
0
Composite score
Baseline established
Score across visits Illustrative
Baseline6 mo12 mo18 mo24 mo
Reaction 0ms
Accuracy 0%
vs. base 0
0.2M Americans age 65+ live with Alzheimer's dementia today — projected to reach 13.8M by 2060 Alzheimer's Assoc. Facts & Figures, 2025
0.4M US adults 50+ have MCI or mild dementia due to Alzheimer's (6.9M MCI + 2.5M mild dementia) Neurology / AAN, 2022
0.7% global prevalence of mild cognitive impairment in adults over 50 (meta-analysis of 233 studies) Meta-analysis, 676,974 individuals, 2023
0.9% of US adults 45+ report subjective cognitive decline — fewer than half have told a provider CDC / BRFSS analysis, 2023 data
The detection gap

Most cognitive impairment is never caught early.

The population is enormous and growing — yet early cognitive change routinely goes undetected in the visits where it could first be found. Better, repeatable measurement in primary care is the widely-called-for fix.

  • ~8% of expected MCI cases are actually diagnosed in Medicare primary care — 99.9% of clinicians diagnose below expected rates.
  • ~1 in 5 primary-care patients age 55+ had undiagnosed cognitive impairment in a screened sample (20.8%).
  • More than half of patients with dementia had never had a cognitive evaluation — despite Medicare reimbursement.
  • Fewer than half (42.8%) of adults 45+ reporting memory concerns had discussed them with a provider.
MCI diagnosed in primary care Published Medicare rate

Only about 8% of expected MCI cases are diagnosed in Medicare primary care.

One score vs. a personal trend Illustrative
Individual trend Population reference
Base6mo12mo18mo24mo
Why serial measurement

Change from a person's own baseline is the signal.

A single score is hard to read — people vary widely, and a number near a population average can hide meaningful decline from where that person started. DANA is built for repeated, standardized administration, so clinicians can follow within-person change over time instead of guessing from one snapshot.

  • Establish an individual cognitive baseline in about 5 minutes.
  • Re-measure at clinically meaningful intervals and compare against that baseline.
  • Review reaction time, accuracy, and the composite score as a trend line — export PDF and CSV.
FDA-cleared scope

Conditions & factors DANA helps you assess.

DANA's FDA clearance covers a broad set of conditions and factors that can affect reaction time — the ones most relevant to cognitive impairment are below. See the full cleared indications for use →

Memory impairment Dementia Delirium Depression Prescription & non-prescription medication effects Fatigue & stress

DANA measures reaction time and accuracy to aid a qualified professional's assessment — it does not diagnose these conditions. DANA is not a diagnostic tool.

The workflow

Baseline. Re-measure. Document the trend.

A five-minute loop that fits the Annual Wellness Visit and follow-up care.

01

Baseline

Capture an individual baseline when a memory concern is raised or at a wellness visit — fast, standardized, self- or staff-administered.

02

Re-measure

Reassess at meaningful intervals — annual visits, follow-ups, or during treatment monitoring — in-clinic or remotely, online or offline.

03

Document the trend

Review change against baseline in the web portal and export PDF summaries and raw CSV for the record and for referral.

Implementation model

Example: Annual Wellness Visit workflow.

The AWV includes a cognitive-assessment requirement but doesn't mandate a specific instrument.

01

Administer during the AWV

Complete the 5-minute battery as part of the Medicare Annual Wellness Visit's required cognitive assessment.

02

Establish or update baseline

The first visit establishes a baseline; return visits compare against the patient's own prior AWV results.

03

Flag meaningful change

Identify decline that exceeds normal year-to-year variability, not just a single low score.

04

Route to further evaluation

Refer patients showing meaningful decline for a fuller workup or specialist evaluation.

05

Support documentation for the visit

Export a summary for the AWV record, supporting the visit's cognitive-assessment requirement.

06

Track year over year

Build a longitudinal record across multiple AWVs to see the patient's actual trajectory over time.

Coding and coverage should be verified with current payer policy. DANA is not a diagnostic tool.

Where it fits

Built for the settings where memory concerns surface.

Primary care & the AWV

Support the Annual Wellness Visit's cognitive-assessment requirement with a fast, standardized, repeatable baseline — no specific instrument is mandated.

Neurology & memory clinics

Add objective, longitudinal reaction-time and accuracy data to a fuller evaluation — trackable across visits against each patient's own baseline.

Senior care & aging programs

Screen and re-screen at scale with multi-subject lists — practical for aging-services and residential settings tracking many individuals over time.

Treatment monitoring

The new anti-amyloid therapies target the MCI-to-mild-dementia window and involve ongoing monitoring — DANA adds objective, repeatable cognitive follow-up alongside required medical monitoring.

5-minute, low burden

Short enough to fit a routine visit and gentle enough for older adults — self- or staff-administered, in-clinic or at home.

Compliant & cleared

FDA-cleared; HIPAA, 21 CFR Part 11 & SOC 2 Type II compliant; BAA available; encrypted in transit and at rest.

Reimbursable

Reimbursed by commercial and federal payers when medically necessary — a revenue line for your practice, not just documentation overhead.

Program implementation & management

Our operations team works with you from day one through ongoing use to help ensure program success — we don't just hand you software and expect you to figure out workflows on your own.

A new treatment era

Early detection now changes what's possible.

Two FDA-approved anti-amyloid therapies — lecanemab (Leqembi, 2023) and donanemab (Kisunla, 2024) — are indicated specifically for people with MCI or mild dementia due to Alzheimer's, the exact early window that so often goes undetected. Their arrival raises the stakes on finding and following cognitive change early, with baseline-and-serial measurement over the course of care.

Not a diagnostic or medical-monitoring device. DANA supports objective cognitive measurement interpreted by qualified professionals. It does not diagnose Alzheimer's or replace the medical monitoring these therapies require.

Schedule a Demo See the baseline & tracking workflow.
Documentation & value

Objective evidence for the record.

DANA supports objective documentation that can accompany medical-necessity discussions — baseline, intervention, and follow-up comparisons in one exportable report. When medically necessary, DANA is reimbursed by commercial and federal payers.

Request the Interpretation Report Request a Reimbursement Guide Sent to your inbox — no account required.
Next step

Bring objective, longitudinal cognition to memory care.

See the baseline-and-track workflow, the trend view, and how it fits primary care, neurology, and senior care.

Schedule a Demo