Beta amyloid oligomers in the early diagnosis of AD and as marker for treatment response

Beta amyloid oligomers in the early diagnosis of AD and as marker for treatment response - EDAR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31716

Enrollment

100

Registered

2007-10-11

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Alzheimer's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Dementia or mild cognitive impairment according to established clinical criteria

Exclusion criteria

Exclusion criteria: Contra indication for lumbar puncture Score on Mini Mental State examination below 18 Co-morbid disorders that have a major impact on cognition Age below 40 (demented subjects and controls) or below 60 (subjects with mild cognitive impairment) Cognitive impairment (control subjects)

Design outcomes

Primary

Measure	Time frame
- Area under the curve (AUC) of a Receiver Operating Characteristic (ROC) curve for the ability of beta amyloid oligomers to differentiate subjects with AD from control subjects and subjects with other types of dementia. - AUC of a ROC curve for the ability of beta amyloid oligomers to differentiate subjects with MCI who progressed to AD at follow-up from those who will remain stable. - AUC of ROC curves to investigate the difference in diagnostic accuracy for AD of beta amyloid oligomers compared to other biomarkers of AD. - Differences in oligomer levels according to genotype. - Change over time of oligomer levels in control subjects, subjects with MCI, and subjects with AD. Additional outcome for amendment: - Difference in gene expression profiles between subjects with high and low beta amyloid oligomer levels.	—

Measure

Time frame

- Area under the curve (AUC) of a Receiver Operating Characteristic (ROC) curve for the ability of beta amyloid oligomers to differentiate subjects with AD from control subjects and subjects with other types of dementia. - AUC of a ROC curve for the ability of beta amyloid oligomers to differentiate subjects with MCI who progressed to AD at follow-up from those who will remain stable. - AUC of ROC curves to investigate the difference in diagnostic accuracy for AD of beta amyloid oligomers compared to other biomarkers of AD. - Differences in oligomer levels according to genotype. - Change over time of oligomer levels in control subjects, subjects with MCI, and subjects with AD. Additional outcome for amendment: - Difference in gene expression profiles between subjects with high and low beta amyloid oligomer levels.

—

Secondary

Measure	Time frame
- Correlation between cognitive markers and levels of beta amyloid oligomers cross-sectionally and over time.	—

Countries

Netherlands

Outcome results