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Alzheimer's DiseasePhase 4NCT00120874

Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training

A Phase 4 study testing Individualized management of AD including caregiver training and Memantine in people with Alzheimer's Disease, run by NYU Langone Health 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

The purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer's Disease
What is being tested?
Individualized management of AD including caregiver training and Memantine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Aug 2006to Nov 2011
Phase
Phase 4
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients, 50 years of age or greater, residing in the community
  • Presence of a family and/or professional caregiver willing and able to participate in all aspects of this study
  • A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al., Neurology,1984;34: 939-944) criteria
  • A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA diagnostic criteria for Alzheimer's disease
  • Mini-Mental State Examination scores of 3-14
  • Global Deterioration Scale stages of 5 or 6
  • A stage of 6a or greater on the Functional Assessment Staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living

Who cannot join

  • Non-English speaking patients and/or caregivers
  • Subjects with a diagnosis of dementia due to conditions other than Alzheimer's disease.
  • Subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified Hachinski Ischemic Rating scale
  • Patients with a major depressive disorder
  • Patients with clinically significant laboratory abnormalities
  • Patients receiving investigational pharmacologic agents

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fisher Alzheimer's Program, New York University School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

Official title: Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial

The purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe Alzheimer's disease.

Read the detailed description

Presently some 4.5 million people are afflicted with Alzheimer's disease in the United States. At present pharmacologic treatment, although beneficial, is not curative. Certain nonpharmacologic treatments have assisted caregivers of AD patients by reducing their stress and burden, and others have aided patients, by improving their mood and physical functioning. Comprehensive, individualized approaches to improving Alzheimer's patients' symptomatology and caregiver stress and burden have not been systematically investigated in Alzheimer's patient care. This study seeks to train and counsel caregivers as well as develop an individualized, comprehensive management program that will seek to enhance the functioning of each patient participant.

Patients are randomly placed into one of two groups. Both groups receive memantine and comprehensive evaluations at baseline, 4, 12,28 and 52 weeks. Additionally, group 1 receives an individualized management program, which consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.

Being tested
Individualized management of AD including caregiver training, Memantine
Keywords
Alzheimer's disease, caregiver training, caregiver counseling, individualized management, memantine, dementia
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

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

  • Individualized management of AD including caregiver trainingBehavioural

    Also called Namenda, Activity therapy, Cognitive stimulation therapy, Exercise

    Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.

  • MemantineDrug

    Also called Namenda

    Patients receive 10 milligrams of memantine twice daily.

Study groups in NCT00120874
Study groupRoleWhat they receive
Group 1ExperimentalIndividualized Management including caregiver training and Memantine
Receives: Behavioral: Individualized management of AD including caregiver training; Drug: Memantine
Group 2Active comparatorOnly Memantine
Receives: Drug: Memantine

What is being measured

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

  1. Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

    CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse

    Measured: Baseline to 28 weeks

  2. Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)

    CIBIC-Plus is measured in units on a scale ranging from 1 to 7, where 1 is markedly improved, 4 is unchanged, and 7 is markedly worse

    Measured: Baseline to 52 weeks

  3. Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

    The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.

    Measured: Baseline to 28 weeks

  4. Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)

    The ADCS-ADLsev-abv is a structured questionnaire where each item consists of a series of hierarchical questions designed to determine a patient's ability to perform the activities of daily living as assessed by the caregiver. Possible scores range from 0 to 39, where a higher score is indicative of greater capacities.

    Measured: Baseline to 52 weeks

Secondary outcomes (12)

  1. Change From Baseline of the Severe Impairment Battery (SIB)

    The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).

    Measured: Baseline to 28 weeks

  2. Change From Baseline of the Severe Impairment Battery (SIB)

    The SIB evaluates cognitive performance. It is a 51 item scale which assesses social interaction, memory, language, orientation, attention, praxis, visuospacial ability and construction. Scores range from 0 (greatest impairment) to 100 (least impairment).

    Measured: Baseline to 52 weeks

  3. Change From Baseline of the Mini-Mental State Examination (MMSE)

    The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.

    Measured: Baseline to 28 weeks

  4. Change From Baseline of the Mini-Mental State Examination (MMSE)

    The MMSE is a graded on a 30 point scale that measures cognitive functioning. A lower score indicates a higher level of impairment. Complete scale range is -no cognitive impairment=24-30; mild cognitive impairment=18-23; severe cognitive impairment=0-17.

    Measured: Baseline to 52 weeks

  5. Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

    The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.

    The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)

    Measured: Baseline to 28 weeks

  6. Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)

    The FAST-DS assesses the magnitude of progressive functional deterioration by identifying characteristic progressive disabilities in participants with AD. Scores range from 1.0 (normal) to 7f (severe loss of ability, not even able to hold up head independently). Scores are made up of stages (1 through 7) and substages (from a to e for stage 6; from a to f for stage 7). The following scoring for substages is applied: 6a=6.0, 6b=6.2, 6c=6.4, 6d=6.6, 6e=6.8, 7a=7.0, 7b=7.2, 7c=7.4, 7d=7.6, 7e=7.8, 7f=8.0. Additionally, non-consecutive deficits are noted and scored as follows: full stage non-consecutive deficit=1.0, non-consecutive substage deficit=0.2.

    The overall FAST-DS score = (FAST Stage Score) + (Each Non-Consecutive FAST disability scored as described)

    Measured: Baseline to 52 weeks

  7. Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

    The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). Global rating was not analyzed for this study. The higher the score the worse the outcome.

    Measured: Baseline to 28 weeks

  8. Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)

    The BEHAVE-AD-FW measures the frequency and severity of 25 behavioral symptoms with a total score and global rating. Individual behavioral assessments are rated for severity (0=none to 3-most severe) and frequency (1=least frequent to 4=most frequent) which are then multiplied; scores for each of the 25 items are then summed. Possible total scores range from 0 to 297. The global rating is scored from 0 (not dangerous to patient, not troubling to caregiver) to 3 (dangerous to patient, highly troubling to caregiver). The higher the score the worse the outcome.

    Measured: Baseline to 52 weeks

  9. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.

    Measured: Baseline to 28 weeks

  10. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.

    Measured: Baseline to 28 weeks

  11. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency

    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.

    Measured: Baseline to 52 weeks

  12. Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction

    The RMBPC is a 24 item rating scale of the frequency of memory and behavioral problems in the AD subject and of how upset or "bothered" their caregivers react. Frequency is rated from 0 (least frequent) to 4 (most frequent) and caregiver reaction is rated from 0 (not at all) to 4 (extremely bothered or upset). Higher scores indicate more frequent memory and behavioral problems in the subject with AD as well as a more upset or bothered caregiver. Possible scores range from 0 to 96.

    Measured: Baseline to 52 weeks

Timeline

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

  1. First posted19 Jul 2005 (estimated)
  2. Study startAug 2006
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

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 4
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120874
Sponsor's protocol ID
H12444-01 A
Other IDs
NAM MD 18
Status last verified
Sep 2016
First submitted
12 Jul 2005
Last updated
25 Oct 2016
Data monitoring committee
Yes

Publications

  • Reisberg B, Kenowsky S, Franssen EH, Auer SR, Souren LE. Towards a science of Alzheimer's disease management: a model based upon current knowledge of retrogenesis. Int Psychogeriatr. 1999 Mar;11(1):7-23. doi: 10.1017/s1041610299005554.

    PubMed 10189596

  • Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015.

    PubMed 14559955

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Individualized management of AD including caregiver training and Memantine in people with Alzheimer's Disease, run by NYU Langone Health 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 7 inclusion and 6 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 25 Oct 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 14 Jul 2016). 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?

Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version) (time frame: Baseline to 28 weeks). The study lists 4 primary outcomes in all. 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 NCT00120874, which also lists 2 linked publications.

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 25 Oct 2016.

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