NCT03900936

Brief Summary

Aims

  1. 1.To determine whether the 4 Mountains test of allocentric (i.e. viewpoint-independent) spatial memory, and tests of memory for a recent experience (e.g. watching a brief video), to diagnose the early stages of Alzheimer's disease.
  2. 2.We operationalise this as the ability of these tests to predict whether or not an individual progresses from having some cognitive difficulties (diagnosed as 'mild cognitive impairment' MCI) to subsequently developing Alzheimer's disease up to two years later.
  3. 3.To assess whether the ability to diagnose early stages of Alzheimer's disease can be improved by combining the scores from different memory tests, from questionnaires assessing spatial and social aspects of everyday life.
  4. 4.To assess whether scores on the spatial memory test are correlated with patients' reports of their everyday spatial memory, using a newly-developed questionnaire.
  5. 5.To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease.
  6. 6.To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 19, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

April 3, 2019

Status Verified

April 1, 2019

Enrollment Period

2.4 years

First QC Date

April 1, 2019

Last Update Submit

April 2, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Predicting progression

    To determine the ability of allocentric spatial and episodic memory test performance to predict progression from mild cognitive impairment (MCI) to Alzheimer's disease.

    3 years

  • Social Characteristics and questionnaires

    1. To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease. 2. To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.

    3 years

Study Arms (1)

Neuropsychological tests

This study is not an intervention as such. We are simply comparing the scores of MCI patients who subsequently went on to develop dementia vs those who did not.

Diagnostic Test: Neuropsychological tests

Interventions

This study is not an intervention as such. We are simply comparing the scores of MCI patients who subsequently went on to develop dementia vs those who did not.

Neuropsychological tests

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with mild cognitive impairment (MCI) will be recruited from memory clinics from several different trusts, including NHS South Tees NHS FT and NHS Tees, Esk and Wear Valleys NHS FT. The diagnosis of MCI will be made by clinicians in accordance with the four core clinical criteria of Albert et al (2011). Briefly, these are: 1) Evidence of change (worsening) in cognition; 2) Impairment in one or more cognitive domains greater than expected for age/education; 3) Preservation of independence in functional abilities; 4) No current dementia.

You may qualify if:

  • MCI diagnosis.

You may not qualify if:

  • \. Presence of significant neurological condition such as Traumatic Brain Injury, Epilepsy, Stroke, Multiple Sclerosis, Brain tumour, Encephalitis, Meningitis, Parkinson's disease or visual impairment severe enough to hamper processing of visual test stimuli.
  • \. Major psychiatric disorder, such as schizophrenia, bipolar disorder and personality disorders such as borderline personality disorder. We will exclude severe (but not mild or moderate) clinical depression, and will exclude severe (but not mild or moderate) anxiety.
  • \. The use of cognitive enhancing drugs e.g. Cholinesterase inhibitors. 4. A history of alcohol excess or excess of illicit drug use within the last 5 years.
  • (By definition, the diagnosis of dementia excludes a participant, since this would conflict with the fourth basis for the MCI diagnosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Tees Hospitals NHS FT

Middlesbrough, Teesside, TS4 3BW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

January 19, 2017

Primary Completion

June 20, 2019

Study Completion

August 30, 2021

Last Updated

April 3, 2019

Record last verified: 2019-04

Locations