Mild Cognitive ImpairmentPhase 1NCT00714571

Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)

A Phase 1 study testing Mnemonic strategy training (MST), Repeated exposure (XP) and Subtracting Cues training in people with Mild Cognitive Impairment and Alzheimer's Disease, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of various forms of dementia, such as Alzheimer's disease and its common precursor mild cognitive impairment (MCI). This project intends to assess the efficacy of cognitive rehabilitation in these patient populations. Read more about this study

Who is it for?: Ages 18 to 88 yearsHealthy volunteers can take part
Conditions the study is for: Mild Cognitive Impairment, Alzheimer's Disease, Traumatic Brain Injury
What is being tested?: Mnemonic strategy training (MST), Repeated exposure (XP) and Subtracting Cues training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Sep 2014
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 18 to 88 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

General inclusion criteria (all patients):
A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma;
All medications stable for approximately 3 months;
No history of severe mental illness;
No current untreated alcohol or substance abuse/dependence;
English as native and preferred language;

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MRI-compatible if taking part in fMRI studies 7) Able to give informed consent.
MCI Inclusion Criteria:
Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
55 years of age or older.
TBI Inclusion criteria:
History of a mild to moderate TBI;
No history of other neurological disease or injury;
A minimum of 6 months and maximum of 5 years post-onset of TBI;
18 - 45 years old.

Who cannot join

History of neurological disease or injury (other than TBI)
History of severe mental illness
Current untreated alcohol or substance abuse
Other conditions may exclude; please discuss with contact

Trial locations and contacts

1 site in 1 country.

United States1 site

Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033

Other trials in United States

About this study

Official title: Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI

Conditions: Mild Cognitive Impairment, Alzheimer's Disease, Traumatic Brain Injury
Being tested: Mnemonic strategy training (MST), Repeated exposure (XP), Subtracting Cues training
Keywords: cognitive rehabilitation, explicit memory training, mild cognitive impairment, Alzheimer's disease, traumatic brain injury, veterans
Medical subject headings: Cognitive Dysfunction, Alzheimer Disease, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mnemonic strategy training (MST)Behavioural
Repeated exposure (XP)Behavioural
Subtracting Cues trainingBehavioural

Study groups in NCT00714571
Study group	Role	What they receive
MST healthy older adults Stage 1	Active comparator	Mnemonic strategy training Receives: Behavioral: Mnemonic strategy training (MST)
MST MCI Stage 1	Active comparator	Exposure training Receives: Behavioral: Mnemonic strategy training (MST)
XP healthy older adults Stage 1	Active comparator	XP healthy older adults Stage 1 Receives: Behavioral: Repeated exposure (XP)
XP MCI Stage 1	Active comparator	XP MCI Stage 1 Receives: Behavioral: Repeated exposure (XP)
MST healthy older adults Stage 2	Active comparator	MST healthy older adults Stage 2 Receives: Behavioral: Mnemonic strategy training (MST)
SCT healthy older adults Stage 2	Active comparator	SCT healthy older adults Stage 2 Receives: Behavioral: Subtracting Cues training

What is being measured

The primary outcome is the main question the study is designed to answer.

Memory Test Accuracy on Trained Stimuli
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test
Measured: Pre-training, post-training, 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Sep 2014

First posted14 Jul 2008 (estimated)
Study startJul 2008
Primary completionSep 2014
Study completionSep 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Single blind
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00714571
Sponsor's protocol ID: B6366-W
Status last verified: Nov 2016
First submitted: 8 Jul 2008
Last updated: 4 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hampstead BM, Sathian K, Phillips PA, Amaraneni A, Delaune WR, Stringer AY. Mnemonic strategy training improves memory for object location associations in both healthy elderly and patients with amnestic mild cognitive impairment: a randomized, single-blind study. Neuropsychology. 2012 May;26(3):385-99. doi: 10.1037/a0027545. Epub 2012 Mar 12.
PubMed 22409311

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI
ClinicalTrials.gov ID: NCT00714571
Acronym / sponsor ID: B6366-W
Conditions: Mild Cognitive Impairment, Alzheimer's Disease, Traumatic Brain Injury
Keywords: cognitive rehabilitation, explicit memory training, mild cognitive impairment, Alzheimer's disease, traumatic brain injury, veterans
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Emory University
Study start: Jul 2008
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 14 Jul 2008 (estimated)
Results: Posted 4 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Number of arms: 6

Arm	Type	Receives
MST healthy older adults Stage 1	Active comparator	Behavioral: Mnemonic strategy training (MST)Mnemonic strategy training
MST MCI Stage 1	Active comparator	Behavioral: Mnemonic strategy training (MST)Exposure training
XP healthy older adults Stage 1	Active comparator	Behavioral: Repeated exposure (XP)XP healthy older adults Stage 1
XP MCI Stage 1	Active comparator	Behavioral: Repeated exposure (XP)XP MCI Stage 1
MST healthy older adults Stage 2	Active comparator	Behavioral: Mnemonic strategy training (MST)MST healthy older adults Stage 2
SCT healthy older adults Stage 2	Active comparator	Behavioral: Subtracting Cues trainingSCT healthy older adults Stage 2

Who may qualify

Ages: 18 to 88 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma;
All medications stable for approximately 3 months;
No history of severe mental illness;
No current untreated alcohol or substance abuse/dependence;
English as native and preferred language;

Key exclusion criteria (4 listed)

History of neurological disease or injury (other than TBI)
History of severe mental illness
Current untreated alcohol or substance abuse
Other conditions may exclude; please discuss with contact

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
Mnemonic strategy training (MST)	Behavioural	MST MCI Stage 1, MST healthy older adults Stage 1, MST healthy older adults Stage 2
Repeated exposure (XP)	Behavioural	XP MCI Stage 1, XP healthy older adults Stage 1
Subtracting Cues training	Behavioural	SCT healthy older adults Stage 2

Primary outcome

Memory Test Accuracy on Trained Stimuli
Time frame: Pre-training, post-training, 1 month
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test

Results and safety

Results posted to the registry on 4 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MST Healthy Older Adults: Stage 1	12	12
MST MCI: Stage 1	15	15
XP Healthy Older Adults: Stage 1	11	10
XP MCI: Stage 1	14	14
MST Healthy Older Adults: Stage 2	0	0
SCT Healthy Older Adults: Stage 2	0	0

Primary outcome: Memory Test Accuracy on Trained Stimuli

Time frame: Pre-training, post-training, 1 month. Mean (Standard Deviation). Unit: Percent correct

Measure	MST Healthy Older Adults: Stage 1 n = 11	MST MCI: Stage 1 n = 14	XP Healthy Older Adults: Stage 1 n = 10	XP MCI: Stage 1 n = 14	MST Healthy Older Adults: Stage 2 n = 15	SCT Healthy Older Adults: Stage 2 n = 15
Pre-training	53.9 (10.2)	37.6 (15.0)	48.9 (14.5)	37.3 (8.7)	59.8 (14.0)	57.6 (15.3)
Post-Training	97.0 (4.0)	82.5 (14.7)	92.0 (6.9)	71.4 (13.2)	94.9 (4.8)	83.7 (13.7)
1-month	85.3 (1.01)	65.1 (17.8)	63.3 (13.7)	45.8 (8.3)	86.2 (7.4)	69.7 (18.1)

Population analysed: MST older adults Stage 1: 1 participant excluded due to undisclosed ongoing chemotherapy treatment XP older adults Stage 1: 1 participant decided not to participate after randomization MST MCI Stage 1: 1 participant diagnosed with Alzheimer's dementia within 1 month of completing study

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MST Healthy Older Adults: Stage 1	0 of 12 (0%)	0 of 12 (0%)	Not reported
MST MCI: Stage 1	0 of 15 (0%)	0 of 15 (0%)	Not reported
XP Healthy Older Adults: Stage 1	0 of 11 (0%)	0 of 11 (0%)	Not reported
XP MCI: Stage 1	0 of 14 (0%)	0 of 14 (0%)	Not reported
MST Healthy Older Adults: Stage 2	0 of 15 (0%)	0 of 15 (0%)	Not reported
SCT Healthy Older Adults: Stage 2	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22409311Hampstead BM, Sathian K, Phillips PA, Amaraneni A, Delaune WR, Stringer AY. Mnemonic strategy training improves memory for object location associations in both healthy elderly and patients with amnestic mild cognitive impairment: a randomized, single-blind study. Neuropsychology. 2012 May;26(3):385-99. doi: 10.1037/a0027545. Epub 2012 Mar 12.

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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.

Benjamin M. Hampstead, PhD principal investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 4 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 4 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 4 Jan 2017). 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?

Memory Test Accuracy on Trained Stimuli (time frame: Pre-training, post-training, 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00714571, which also lists 1 linked publication.

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 4 Jan 2017.