Patient- and care-related benefits of amyloid PET imaging

Phase 4

• Conditions: F03; F00.0; F00.1; F00.2; F00.9; Unspecified dementia; Dementia in Alzheimer disease with early onset; Dementia in Alzheimer disease with late onset; Dementia in Alzheimer disease, atypical or mixed type; Dementia in Alzheimer disease, unspecified

• Registration Number: DRKS00030839
• Lead Sponsor: Deutsches Zentrum für Neurodegenerative Erkrankungen e. V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1126

Inclusion Criteria

Mild to moderate dementia syndrome.
- Clinical Dementia Rating Scale (CDR-SB) greater than 0.5 and less than 3.0 and Mini-Mental Status Examination (MMSE) greater than 10
- Unclear diagnosis of dementia or uncertain diagnosis of Alzheimer's disease (diagnostic certainty less than 85 percent).
- At least 15 percent probability of Alzheimer's disease, i.e., Alzheimer's disease cannot be excluded with certainty.
- Diagnosis by examination of the cerebrospinal fluid is not possible because a) the patient has a contraindication to CSF puncture, b) the patient refuses CSF puncture or c) the diagnosis remains unclear after CSF puncture.
- Patients who would agree in principle to undergo amyloid PET diagnostics and are willing to receive the results if randomised to the amyloid PET arm.
- Written informed consent, either by the patient or the legal representative according to the presumed will of the patient
- Accompanied by an authorised/qualified informant
- Patients with valid insurance cover from a German statutory health insurance company

Exclusion Criteria

- Severe dementia (CDR score equal to 3 and/or an MMST score less than or equal to 10).
- Mild cognitive impairment, CDR score less than or equal to 0.5, absence of cognitive impairment relevant to daily living
- Patients in whom radiation exposure must be avoided
- Pregnancy or breastfeeding at the time of the amyloid PET measurement (for women who are less than 12 months postmenopausal, a pregnancy test is carried out before the amyloid PET-measurement)
- Patients who are currently participating in another clinical trial with investigational medication or within 5 half-lives of the investigational medication of another clinical trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ability to manage activities of daily living as measured by the Amsterdam Instrumental Activities of Daily Living Questionnaire© (A-IADL-Q) score 78 weeks after randomization.