NCT04533204

Brief Summary

This study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. Participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. Participants returned 1 month after treatment to see how well they remembered the learned information. Brain scans (functional MRI) were collected before and after the interventions to see if training changed the way brain regions were functioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2014

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

November 1, 2020

Enrollment Period

3.9 years

First QC Date

August 25, 2020

Results QC Date

November 18, 2020

Last Update Submit

February 26, 2021

Conditions

Keywords

MCIcognitive trainingmemory trainingdementiaAlzheimer's disease

Outcome Measures

Primary Outcomes (1)

  • Percent of Correct Object Location Associations Assessed up to 1 Month Post-treatment

    Change in memory for 45 trained object location associations

    up to 1 month after last training session

Secondary Outcomes (1)

  • Change in Accuracy (vs. Baseline) on Novel Object Location Associations

    up to 1 month after last training session

Study Arms (2)

Mnemonic strategy training

EXPERIMENTAL

Training using mnemonic strategies

Behavioral: mnemonic strategy training

Spaced retrieval training

ACTIVE COMPARATOR

Training using spaced retrieval

Behavioral: spaced retrieval training

Interventions

training using mnemonic strategies

Mnemonic strategy training

training using spaced retrieval

Spaced retrieval training

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of MCI according to Petersen (2004) criteria, right handed

You may not qualify if:

  • Diagnosis of other neurological condition,
  • active drug/alcohol abuse/dependence,
  • moderate-severe depression or other Axis I diagnoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Dr. Benjamin Hampstead
Organization
VA Ann Arbor Healthcare System; University of Michigan

Study Officials

  • Benjamin M. Hampstead, PhD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were informed they would receive one of two cognition oriented treatments but were unaware of the nature of the other intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization to Mnemonic strategy or spaced retrieval training
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 31, 2020

Study Start

August 1, 2010

Primary Completion

June 30, 2014

Study Completion

July 30, 2014

Last Updated

March 23, 2021

Results First Posted

March 23, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations