Alzheimer DiseasePhase 1NCT00593372
Treatment of Language and Memory in Patients With Alzheimer's Disease
A Phase 1 study testing Spaced Retrieval Training in people with Alzheimer Disease, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to collect data on the effects of behavioral interventions for memory and communication deficits in persons taking cholinesterase inhibitors compared with the effects of cholinesterase inhibitors alone. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Spaced Retrieval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Apr 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alzheimer's Disease (middle stage)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Language and Memory in Patients With Alzheimer's Disease: A Comparison Between Drug Therapy and Drug Therapy Plus Behavioral Intervention
The purpose of this study is to collect data on the effects of behavioral interventions for memory and communication deficits in persons taking cholinesterase inhibitors compared with the effects of cholinesterase inhibitors alone. Initial testing will include a written case history, tests of communication skills, and interviews with the participants, family, and staff caregivers to help select potential goals for treatment. Participants will be randomly selected to participate in Group A (control) or Group B (intervention). Group A will use a Caregiver Checklist for eight weeks to identify any increase or decrease in the occurrence of the identified communication deficits. Group B will have 16 treatment sessions by a Speech Language Pathologist during the eight-week period. A post test will be administered to all participants.
Read the detailed description
Patients with dementia suffer from a variety of cognitive-linguistic deficits, including attention, orientation, memory, anomia, and pragmatics. Behavioral treatment of these deficits falls within the domain of speech-language pathology. While no efficacy studies have emerged to demonstrate the benefit of speech-language therapy for individuals who suffer Alzheimer's disease (AD), data are emerging which support the positive effects of memory and communication intervention in this population. Phase I and Phase II investigations are beginning to provide evidence that such intervention should focus on the development of innovative strategies to help patients compensate for the disabilities resulting from the disease rather than on traditional rehabilitation of impairment. The benefits of cholinesterase inhibitors for improving cognitive function in persons with AD have been demonstrated, and data continue to emerge on specific drugs and specific changes in cognitive processes. The purpose of the proposed investigation would be to collect pilot data on the effects of behavioral intervention for memory and communication deficits in conjunction with cholinesterase inhibitors, as compared with the effects of cholinesterase inhibitors used in isolation. Participants will be individuals with AD who are recruited from the Alzheimer's Disease Center at The University of Arkasas for Medical Sciences Medical Center. All participants will be taking cholinesterase inhibitors, and half of all participants will be randomly selected to receive intervention by a speech-language pathologist. Intervention will consist of 16 treatment sessions (one hour each) over a two month period and will focus on strategies for enhancing memory and functional communication.
- Conditions
- Alzheimer Disease
- Being tested
- Spaced Retrieval Training
- Keywords
- Alzheimer's Disease, Memory, Treatment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spaced Retrieval TrainingBehavioural
Increasing time to remember important information.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Drug Plus Behavioral Therapy Receives: Behavioral: Spaced Retrieval Training |
| II | No intervention | Drug Therapy Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Successful Memory Tasks Completed Over Study Period.
Successful memory tasks are those memory tasks (such as "where do I keep my keys") that participants are able to consistently respond to.
Measured: 8 weeks
Secondary outcomes (1)
Change on Mini-Mental State Examination
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startAug 2003
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary H McCullough, Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593372
- Sponsor's protocol ID
- g1-10532-03-07
- Status last verified
- Nov 2016
- First submitted
- 2 Jan 2008
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Language and Memory in Patients With Alzheimer's Disease: A Comparison Between Drug Therapy and Drug Therapy Plus Behavioral Intervention
- ClinicalTrials.gov ID
- NCT00593372
- Acronym / sponsor ID
- g1-10532-03-07
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Memory, Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 20 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect data on the effects of behavioral interventions for memory and communication deficits in persons taking cholinesterase inhibitors compared with the effects of cholinesterase inhibitors alone. Initial testing will include a written case history, tests of communication skills, and interviews with the participants, family, and staff caregivers to help select potential goals for treatment. Participants will be randomly selected to participate in Group A (control) or Group B (intervention). Group A will use a Caregiver Checklist for eight weeks to identify any increase or decrease in the occurrence of the identified communication deficits. Group B will have 16 treatment sessions by a Speech Language Pathologist during the eight-week period. A post test will be administered to all participants.
Detailed description
Patients with dementia suffer from a variety of cognitive-linguistic deficits, including attention, orientation, memory, anomia, and pragmatics. Behavioral treatment of these deficits falls within the domain of speech-language pathology. While no efficacy studies have emerged to demonstrate the benefit of speech-language therapy for individuals who suffer Alzheimer's disease (AD), data are emerging which support the positive effects of memory and communication intervention in this population. Phase I and Phase II investigations are beginning to provide evidence that such intervention should focus on the development of innovative strategies to help patients compensate for the disabilities resulting from the disease rather than on traditional rehabilitation of impairment. The benefits of cholinesterase inhibitors for improving cognitive function in persons with AD have been demonstrated, and data continue to emerge on specific drugs and specific changes in cognitive processes. The purpose of the proposed investigation would be to collect pilot data on the effects of behavioral intervention for memory and communication deficits in conjunction with cholinesterase inhibitors, as compared with the effects of cholinesterase inhibitors used in isolation. Participants will be individuals with AD who are recruited from the Alzheimer's Disease Center at The University of Arkasas for Medical Sciences Medical Center. All participants will be taking cholinesterase inhibitors, and half of all participants will be randomly selected to receive intervention by a speech-language pathologist. Intervention will consist of 16 treatment sessions (one hour each) over a two month period and will focus on strategies for enhancing memory and functional communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: Spaced Retrieval TrainingDrug Plus Behavioral Therapy |
| II | No intervention | –Drug Therapy Only |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alzheimer's Disease (middle stage)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spaced Retrieval TrainingIncreasing time to remember important information. | Behavioural | I |
Primary outcome
Number of Successful Memory Tasks Completed Over Study Period.
Time frame: 8 weeks
Successful memory tasks are those memory tasks (such as "where do I keep my keys") that participants are able to consistently respond to.
1 secondary outcome
Change on Mini-Mental State Examination
Time frame: End of Study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary H McCullough, Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spaced Retrieval Training in people with Alzheimer Disease, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Successful Memory Tasks Completed Over Study Period. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.