NCT02752750

Brief Summary

In this explorative longitudinal study 50 patients with Alzheimer's disease (AD) and 50 age-matched control subjects will be recruited for their 2 years follow-ups and undergo extensive cognitive testing and quantitative 3 Tesla magnetic resonance imaging (MRI). Regional differences of susceptibility and R2\* relaxation rates in deep gray matter and the neocortex will be evaluated in AD patients and controls and related to the patients´ cognitive status at baseline.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

8 years

First QC Date

April 19, 2016

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantitative magnetic susceptibility (QSM) in the human brain

    Reveal the dynamics of disease related brain iron deposition (by QSM in ppm) and its relation to disease progression and cognition.

    2 years

Study Arms (2)

AD_GROUP

Patients with Alzheimer's disease

Other: MRI

HC_GROUP

Healthy controls

Other: MRI

Interventions

MRIOTHER

MR imaging (MRI) at 3 Tesla

Also known as: Magnetic resonance imaging
AD_GROUPHC_GROUP

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Alzheimer 's Disease

You may qualify if:

  • diagnosis of dementia according to DSM-IV and NINCDS-ADRDA criteria
  • the patient lives either with the family or has less than 40h/week of external care
  • the patients is able to understand the role in this study and is willing to participate
  • the physician in charge of this study confirms that the patients understands the study and its aims according to cognitive and clinical testing

You may not qualify if:

  • are other disorders
  • participation in a clinical drug trial (phase 1-3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Christian Langkammer, PhD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 27, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2024

Study Completion

May 1, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share