Improving early detection of Alzheimer's disease through step-by-step diagnostics

Improving early detection of Alzheimer's disease through step-by-step diagnostics - VERF-AK

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040153

Enrollment

270

Registered

2026-06-17

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(1) Patients with a suspected diagnosis of Dementia (F00.*, F01.*, F02.*, F03.*, G30.*, G31.*) or mild cognitive impairment (F06.7) F00

Interventions

Group 1: Arm 1 will receive the new step-by-step diagnostic approach (intervention group) Group 2: Arm 2 will be referred directly to a diagnostic center as part of standard care (control group).

Eligibility

Sex/Gender

All

Age

50 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Patients with a suspected diagnosis of Dementia (F00.*, F01.*, F02.*, F03.*, G30.*, G31.*) or mild cognitive impairment (F06.7) for whom the non-specialist doctor's office considers a referral to a diagnostic center to be appropriate (2) The patient's capacity to give consent (3) Willingness to participate in the step-by-step diagnostic process and potentially be referred to a diagnostic center (4) Presence of relatives (5) Sufficient German language skills

Exclusion criteria

Exclusion criteria: (1) Moderate to severe dementia or intact cognitive function, as assessed by a general practitioner or a non-specialized medical specialist. (2) Known etiology of Mild Cognitive Impairment (MCI) or mild dementia.

Design outcomes

Primary

Measure	Time frame
The proportion of patients with MCI (mild cognitive impairment) or mild dementia in relation to all patients referred to the DC (diagnostic centers) among the intervention arm and the control arm.	—

Secondary

Measure	Time frame
(1.1) Total number of patients undergoing biomarker testing at the memory clinic (limited to individuals with mild cognitive impairment or mild dementia); (1.2) Total number of patients who do not attend their scheduled appointment at the memory clinic; (1.3) Patient satisfaction with healthcare services; (2.1) Total utilization of diagnostic services per case; (2.2) Direct healthcare costs across all sectors of care; (2.3) Incremental cost-effectiveness ratio (from the statutory health insurance perspective); (2.4) Costs of diagnostic procedures up to confirmation of diagnosis; (2.5) Relative cost composition; (2.6) Health-related quality of life as a utility value and direct as well as indirect healthcare costs (= cost-utility); (2.7) Budget impact.	—

Measure

Time frame

(1.1) Total number of patients undergoing biomarker testing at the memory clinic (limited to individuals with mild cognitive impairment or mild dementia); (1.2) Total number of patients who do not attend their scheduled appointment at the memory clinic; (1.3) Patient satisfaction with healthcare services; (2.1) Total utilization of diagnostic services per case; (2.2) Direct healthcare costs across all sectors of care; (2.3) Incremental cost-effectiveness ratio (from the statutory health insurance perspective); (2.4) Costs of diagnostic procedures up to confirmation of diagnosis; (2.5) Relative cost composition; (2.6) Health-related quality of life as a utility value and direct as well as indirect healthcare costs (= cost-utility); (2.7) Budget impact.

—

Countries

Germany

Contacts

Public ContactFrank Jessen

Universität zu Köln Klinik und Poliklinik für Psychiatrie und Psychotherapie

frank.jessen@uk-koeln.de+49 221 478-4010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026