Treatment of Language and Memory in Patients With Alzheimer's Disease

This study has been completed.

Sponsor:

Information provided by:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT00593372

First received: January 2, 2008

Last updated: July 27, 2010

Last verified: July 2010

History of Changes

Results First Received: April 27, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Alzheimer's Disease. Middle Stage.
Intervention:	Behavioral: Spaced Retrieval Training

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Spaced Retrieval Therapy	Participants continue on current medication but participate in spaced retrieval memory training, as well.
Continuing Medication Only	Participants continue on current medication and are assessed at beginning and end of study duration.

Participant Flow: Overall Study

	Spaced Retrieval Therapy	Continuing Medication Only
STARTED	8 ^[1]	3 ^[2]
COMPLETED	8 ^[3]	3 ^[4]
NOT COMPLETED	0	0

[1]	Eight enrolled in behavioral treatment.
[2]	Three evaluated but only maintained medical treatment.
[3]	Eight completed behavioral treatment.
[4]	Three evaluated and completed protocol.

Baseline Characteristics

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Reporting Groups

	Description
Spaced Retrieval Therapy	Participants continue on current medication but participate in spaced retrieval memory training, as well.
Continuing Medication Only	Participants continue on current medication and are assessed at beginning and end of study duration.
Total	Total of all reporting groups

Baseline Measures

	Spaced Retrieval Therapy	Continuing Medication Only	Total
Number of Participants [units: participants]	8	3	11
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	1	0	1
>=65 years	7	3	10
Age [units: years] Mean ± Standard Deviation	74 ± 5	72 ± 3	72 ± 6
Gender [units: participants]
Female	2	2	4
Male	6	1	7
Region of Enrollment [units: participants]
United States	8	3	11

Outcome Measures

1. Primary:

Number of Successful Memory Tasks Completed Over Study Period. [ Time Frame: 8 weeks ]

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2. Secondary:

Change on Mini-Mental State Examination [ Time Frame: End of Study ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Recruitment of participants was the major limitation of the trial. Alzheimer's patients at facility were asked to participate in so many studies, that participation in this one was challenging.

Results Point of Contact:

Name/Title: Gary McCullough
Organization: UAMS Medical Center
phone: 501-852-7886
e-mail: garyhmccullough@uams.edu

No publications provided

Responsible Party:	Gary H. McCullough, UArkansas
ClinicalTrials.gov Identifier:	NCT00593372 History of Changes
Other Study ID Numbers:	g1-10532-03-07
Study First Received:	January 2, 2008
Results First Received:	April 27, 2010
Last Updated:	July 27, 2010
Health Authority:	United States: Institutional Review Board

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