DZNE – Longitudinal Cognitive Impairment and Dementia Study

Recruiting

• Conditions: G30; F00; Alzheimer disease; Dementia in Alzheimer disease

• Registration Number: DRKS00007966
• Lead Sponsor: Deutsches Zentrum für Neurodegenerative Erkrankungen e. V. (DZNE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

General inclusion criteria:
• informed consent, incl. informed consent for lumbar puncture
• presence of an informant, who is willing to provide information on the participant throughout the study
• presence of an informant, who is not participating in the study and willing to provide information on the healthy control throughout the study
• fluent German language abilities
• age >/= 60 years

Inclusion criteria for respective groups of interest:

SCD Subjects:
• score in the normal range (1.5 SD) of any of the CERAD+ tests at initial clinical assessment prior to study participation in the memory clinic
• patient’s report of cognitive (e.g. memory) decline, about which (s)he expresses concerns (time of onset between the last 6 months and 5 years)

Siblings of patients with AD dementia:
• presence of first degree sibling/ siblings with AD dementia, diagnosed in an expert setting (memory clinic)
• score in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4.

MCI Subjects:
• perform 1.5 SD below the normal range in the delayed recall trial of the CERAD-wordlist at initial clinical assessment prior to study participation in the memory clinic
• subjective cognitive decline by the patient can be present or not
• either the subject or an informant or a clinician has to report a decline in cognitive function causing concerns.
• the subjects must not fulfill dementia criteria.

AD Subjects:
• must fulfill the clinical NINDCS/ADRDA criteria of probable AD (McKhann et al., 2011)

Healthy Controls or 3. Person, who provides information on the particitpantl throughout the study:
• must negate subjective cognitive decline with concerns
•must perform in the normal range of cognitive assessments at the baseline visit according to 2.2.2.4.
• must not have a known first degree relative with dementia (parents > 75y of age or older without dementia)

Exclusion Criteria

• lack of capability to give informed consent
• any condition that clearly interferes with participation in the study
• any condition that interferes with the clinical or neuropsychological study procedures
• sensory impairment that prevents or significantly interferes with neuropsychological testing
• contraindication for both MRI and lumbar puncture
• severe or unstable medical condition
• current major depressive episode
• psychotic disorder, bipolar disorder, substance abuse at present or in the past
• neurodegenerative disorder other than AD
• vascular dementia
• history of stroke with residual symptoms
• clinical significant abnormalities in Vit. B12 or TSH (not applicable for controls and relatives)
• current or past unstable malignant disease with a reduced life expectancy (< 2 years)
• chronic use of psychoactive drugs with sedative or anticholinergic effects
• use of antidementia drugs in SCD, healthy siblings, MCI (Ginkgo is permitted) and in control subjects
• investigational agents for treatment of dementia or cognitive impairment 4 weeks prior to study entry. Participation in a study using investigational medicinal products will lead to exclusion.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is cognitive decline. The cognitive ability is tested longitudinally over 5 years by memory tests (ADAS-cog13, MMSE, FCSRT, SDMT, Digit span test, Clock drawing test, MWT-B) during the annual visits.<br><br>

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is the change in other cognitive domains and leading to a decrease in mental performance and even conversion to dementia. The cognitive ability is tested longitudinally over 5 years by memory tests (ADAS-cog13, MMSE, FCSRT, SDMT, Digit span test, Clock drawing test, MWT-B) during the annual visits.<br><br>