NCT01998711

Brief Summary

Aims: To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive impairment, assisted by family members or friends. To equip persons with mild cognitive impairment with specific skills to prevent memory failures and improve the capacity of patients and families to cope with everyday memory difficulties.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
6.1 years until next milestone

First Posted

Study publicly available on registry

December 2, 2013

Completed
Last Updated

December 2, 2013

Status Verified

September 1, 2005

Enrollment Period

3.1 years

First QC Date

September 12, 2005

Last Update Submit

November 25, 2013

Conditions

Mild Cognitive ImpairmentAlzheimer's Disease

Keywords

Alzheimer's diseaseMild cognitive impairmentMemory interventionStrategy useMemory group

Outcome Measures

Primary Outcomes (6)

  • Neuropsychological measures of memory and attention

  • Self-report on memory performance in everyday activities

  • Self-report on use of memory strategies

  • Informant report on memory performance in everyday activities

  • Informant report on use of strategies

  • Assessment of psychological wellbeing

Study Arms (2)

Memory group

EXPERIMENTAL

Memory training

Behavioral: Memory group

Control

NO INTERVENTION

Standard care

Interventions

Memory groupBEHAVIORAL

Five 1-1.5 hour weekly session of memory training

Memory group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant presents with memory complaint Objective memory impairment on neuropsychological tests Normal general cognitive function Adequate activities of daily living Fails to reach criterion for clinical dementia according to NINCDS-ADRDA guidelines Living in the community Absence of significant visual or auditory impairment English speaker -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caulfield General Medical Centre

Melbourne, Victoria, 3079, Australia

Location

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Glynda J Kinsella, PhD

    Caulfield General Medical Centre - Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

December 2, 2013

Study Start

October 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

December 2, 2013

Record last verified: 2005-09

Locations

AU(1)