NCT03861884

Brief Summary

This prospective study aims:

  1. 1.to compare cognitive performance in different clinical groups of participants with mild cognitive impairment (MCI) or mild dementia \[Alzheimer's Disease (AD), Vascular Cognitive Impairment (VCI) and Fronto-temporal Dementia (FTD)\] to determine whether scores reveal differential profiles between the groups,
  2. 2.to demonstrate differences in imaging markers between different dementia syndromes and healthy volunteers using ultra high-field MRI 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
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

December 12, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
6 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

6.2 years

First QC Date

February 26, 2019

Last Update Submit

March 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neurocognitive scales on Birmingham Cognitive Screen (BCoS) Scores

    cognitive sub scores in relation to clinical phenotype

    Through study completion (an average of one year)

Secondary Outcomes (2)

  • Structural imaging changes on MRI at 3T

    Through study completion (an average of one year)

  • Susceptibility weighted mapping at 7T

    Through study completion (an average of one year)

Study Arms (3)

Cognitive assessments

Neurocognitive assessments, Birmingham Cognitive Screen

MRI at 3T

Brain Imaging: MRI at 3T

Diagnostic Test: Cognitive assessments

MRI at 7T

Brain imaging: Ultrahigh Field MRI at 7T

Diagnostic Test: Cognitive assessments

Interventions

Cognitive assessmentsDIAGNOSTIC_TEST

Cognitive assessment and MRI at 3T and/or 7T

Also known as: MRI at 3T, MRI at 7T
MRI at 3TMRI at 7T

Eligibility Criteria

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

Patients with Alzheimer's disease, Frontotemporal dementia, Vascular Cognitive Impairment

You may qualify if:

  • Ability to give informed consent.
  • Either pathological, genetic or imaging biomarker evidence to suggest Fronto-temporal Lobar Degeneration, Alzheimer's Disease or Vascular Cognitive Impairment, or defined clinical diagnoses.

You may not qualify if:

  • Lack of mental capacity to consent to study involvement.
  • Not speaking English before age 5 years.
  • Learning disability.
  • MRI contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Easat Midland, NG7 2TU, United Kingdom

COMPLETED

Nottingham University Hospitals NHS Trust

Nottingham, East Midland, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

DementiaDisease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Akram Hosseini, MD, PhD

    Akram.Hosseini@nuh.nhs.uk

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 4, 2019

Study Start

December 12, 2018

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 21, 2024

Record last verified: 2024-02

Locations