NCT01329484

Brief Summary

The purpose of this study is to determine whether the use of computerized systems in 2 common non pharmacological therapies (cognitive training and reminiscence therapy) will improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD), or at least delay its deterioration. In addition, the investigators hypothesize that using the computerized systems will result in improved well-being of the patients and their main caregivers / family members, and in improved patient-caregiver and patient-family relations.

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
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

Status
unknown

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

March 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 6, 2011

Status Verified

February 1, 2011

Enrollment Period

1.5 years

First QC Date

March 30, 2011

Last Update Submit

April 3, 2011

Conditions

Alzheimer's Disease

Keywords

AlzheimerDementiaComputerCognitive trainingReminiscence therapy

Outcome Measures

Primary Outcomes (4)

  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.

    baseline

  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.

    Baseline+1 month

  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.

    Baseline+3 months

  • Cognitive function measured by Mindstreams (NeuroTrax Corp., NJ) computerized neuropsychological assessment instrument.

    Baseline+6 months

Study Arms (3)

Cognitive training

EXPERIMENTAL
Behavioral: Cognitive training

Reminiscence therapy

EXPERIMENTAL
Behavioral: Reminiscence therapy

Control

OTHER

This group will receive neither of the above interventions or any other similar interventions

Other: No treatment

Interventions

Reminiscence therapyBEHAVIORAL

Personalized reminiscence therapy using a computerized system

Reminiscence therapy
Cognitive trainingBEHAVIORAL

Cognitive training using a computerized system

Cognitive training
No treatmentOTHER

Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Alzheimer's Disease
  • MMSE score of 14-26

You may not qualify if:

  • Visual impairment
  • Auditory impairment
  • Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mental Health Center

Beersheba, Israel

Location

Memory Clinic, Shaare Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tzvi Dwolatzky, MD

    Mental Health Center, Beer-Sheva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 6, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 6, 2011

Record last verified: 2011-02

Locations

IL(2)