NCT04992975

Brief Summary

A longitudinal observational neuroimaging study of individuals with Early Onset Alzheimer's disease during the prodromal phase, and matched control group - Ultrahigh Field MRI study at 7T

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 21, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 21, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

July 21, 2021

Last Update Submit

March 20, 2024

Conditions

Prodromal Alzheimer's DiseaseMild Cognitive Impairment

Keywords

Ultrahigh Field MRI7T MRIQSM

Outcome Measures

Primary Outcomes (1)

  • Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year

    Relationship between QSM at recruitment and to hippocampal subfield volume (QSM and hippocampal subfield volume are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images)

    one year

Secondary Outcomes (2)

  • cross-sectional and longitudinal changes in QSM in the hippocampal subfields

    one year

  • neuropsychological measures in relation to QSM and volume loss in hippocampal subfields

    one year

Study Arms (2)

Alzheimer's disease

Patients with Early Onset Alzheimer's disease (with known cerebrospinal fluid Amyloid/tau status) during prodromal or mild phase will have MRI of the brain at 7T, neurocognitive assessments, and blood test to check APOe status. Repeat neuroimaging and neurocognitive tests after one year.

Other: MRI at 7T

Control group

Age and gender matched individuals with normal cognition will have MRI of the brain at 7T, neurocognitive assessments and blood test to check APOe status. Repeat neuroimaging, neurocognitive tests after one year.

Other: MRI at 7T

Interventions

MRI at 7TOTHER

MRI at 7T

Alzheimer's diseaseControl group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Alzheimer's Group: Preclinical or Prodromal Alzheimer's disease classified as either A+T-N- or A+T+N- Control Group: individual within 1.5 standard deviation of normal cognition in all tests

You may qualify if:

  • Ability to provide informed consent
  • Patients with pathological diagnosis of Alzheimer's disease according to the National Institute on Aging and Alzheimer's Association, NIA-AA, criteria (Alzheimer's group) or cognitively normal individuals within 1.5 standard deviation of normal in all tests (control group)

You may not qualify if:

  • Lack of mental capacity to consent to study involvement
  • Not speaking English before age 5 years
  • Learning disability
  • Schizophrenia
  • Substance misuse
  • Implanted devices not certified as compatible with ultra-high field MRI (e.g. cardiac pacemaker)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, East Midland, NG7 2UH, United Kingdom

RECRUITING

Related Publications (1)

  • Hari I, Adeyemi OF, Gowland P, Bowtell R, Mougin O, Vesey P, Shah J, Mukaetova-Ladinska EB, Hosseini AA. Memory impairment in Amyloidbeta-status Alzheimer's disease is associated with a reduction in CA1 and dentate gyrus volume: In vivo MRI at 7T. Neuroimage. 2024 Apr 15;292:120607. doi: 10.1016/j.neuroimage.2024.120607. Epub 2024 Apr 12.

    PMID: 38614372DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples will be stored and APOe status will be checked

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Akram Hosseini

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

rebecca Boulton

CONTACT

01159249924Rebecca.Boulton@nuh.nhs.uk

Hannah Sargisson

CONTACT

01159249924Hannah.Sargisson@nuh.nhs.uk

Study Design

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

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 6, 2021

Study Start

September 10, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)