Alzheimer DiseaseNCT03424200
Coaching for Cognition in Alzheimer's (COCOA)
A study testing Routine care and Coaching plus routine care in people with Alzheimer Disease and Cognitive Impairment, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial summary
One major study objective is, using 2 study arms (data-driven health coaching plus RC vs. RC only), to evaluate the efficacy of data-driven health coaching. 'RC only' will serve as the control group. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Cognitive Impairment
- What is being tested?
- Routine care and Coaching plus routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participants must be age 50 and older (no age upper limit) at time of informed consent.
- Adults of any gender, race or ethnicity are eligible to enroll in the study.
- Participants must have cognitive impairment as demonstrated by a Memory Performance Index (MPI) of 50 or below, or delayed free recall score of 6 or below if MPI is greater than 50.
- Participants must have a FAST stage of 2-4.
- Participants with FAST Stage 4 must have the caregiver or legally appointed representative who can provide an appropriate documents (e.g., the power of attorney for healthcare)
- Participants must be proficient in spoken and written English for consenting as well as for study participation since the intervention in this study (e.g., coaching program) is currently only available in English.
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- Participants with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
- Participants, with or without assistance, must be able to use a computer and web interface. If assistance is needed, it must be readily available to them.
- Participants must be able to converse with a coach telephonically. Telephone coaching is part of data-driven health coaching.
- Participants must have regular access to a computer and the Internet along with dedicated email address since certain aspects of the program (e.g. cognitive training) are delivered electronically.
- Participants must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report
- Participants must have adequate hearing acuity as indicated by self-report
- Participants must have adequate motor capacity to use a mobile device/iPad/computer as indicated by self-report
Who cannot join
- Participants with an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Disease, Frontal-Temporal Disease).
- Participants with a diagnosis of cerebrovascular disease as the primary cause of cognitive impairment.
- Participants who have participated in the Arivale program or the HPWP. These employed coaching similar to the approach that will be used in the current study.
- A previously reported AD high-risk mutation (e.g., in the PSEN or APP genes) in the participant or immediate family (children, siblings, or parents). Such patients may accumulate amyloid faster than in late onset AD, and therefore may show less pronounced benefit from intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
One major study objective is, using 2 study arms (data-driven health coaching plus RC vs. RC only), to evaluate the efficacy of data-driven health coaching. 'RC only' will serve as the control group. Participants will be enrolled in the trial on the basis of an existence of objective cognitive impairment defined by the MCI Screen (MCIS) and being in one of three functional stages as defined by the Functional Assessment Staging Test (FAST). The three FAST stages correspond to cognitive impairment without functional impairment (FAST 2), cognitive impairment with functional impairment without impairment in instrumental activities of daily living (FAST 3, also known as mild cognitive impairment, MCI), or cognitive impairment with impaired instrumental activities of daily living (FAST 4). Study objectives include measuring treatment related changes in cognitive and functional abilities, quality of life, and biological or biochemical measures.
A second major study objective is to analyze longitudinal multi-omic data from individuals on a trajectory of early-stage dementia, to discover correlations between measured variables, and identify models of causation that can further advance knowledge and research in brain degeneration and healthy living
Read the detailed description
Up to 200 FAST Stages 2-4 patients with cognitive impairment will be randomized into data-driven health coaching vs. control groups. The participants will be treated and monitored for 24 months.
Subject Identification and Recruitment Study participants will be recruited from a high-volume memory clinic and a large physician medical group. Up to 200 participants will be enrolled in this prospective randomized study (up to 100 in each treatment arm).
Procedures for Obtaining Informed Consent All participants will receive the Experimental Research Subject's Bill of Rights prior to signing the informed consent form (ICF), authorization of use and disclosure of protected health information (PHI), and authorization of medical record release for the subject's treating physician, will be obtained from each participants prior to enrolling in the study. A copy of all signed ICF's will be given to the participants, and the investigator will retain the original.
FAST staging (see Attachment II for the FAST administrating and scoring) will be done before participants are consented to determine whether they or a legally appointed representative (LAR) can consent to participate in the study. In this study, participants with FAST stages 2-4 will be recruited (see Inclusion Criteria).
- Considerations for consenting FAST stages 2-3 subjects: FAST stages 2-3 participants are usually competent to make medical and legal decisions, and will be consented directly, unless there is a caregiver, legally appointed representative, or other reason to think that an informed consent cannot be given by the participants without approval by a reliable informant acting on their behalf.
- Considerations for consenting FAST stage 4 (mild dementia) participants: FAST stage 4 participants will be consented by having them give oral or written assent, indicating their preference with regard to study participation. In addition, the caregiver or legally appointed representative of a demented participants will be consented to assure full understanding of study procedures and willingness on behalf of the participants to participate in the study.
This approach has been evaluated by the Department of Psychiatry and Behavioral Sciences at Johns Hopkins, and found to adequately ensure informed consent (Black et al. 2010). They concluded that ADRD participants should not be excluded from study participation if they cannot directly consent themselves, so long as their caregivers can consent, and the participants can assent, either verbally or in writing, their preference to participate in the study.
The caregiver or legally appointed representative will be required to accompany participants to participate in the required procedures. A copy of the appropriate document (e.g., the power of attorney for healthcare) will be obtained and filed with the original ICF.
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Being tested
- Routine care, Coaching plus routine care
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careBehavioural
Participants will receive routine care
Coaching plus routine careOther
Participants will receive coaching plus routine care
| Study group | Role | What they receive |
|---|---|---|
| Coaching plus Routine Care | Other | Participants will receive coaching plus routine care Receives: Other: Coaching plus routine care |
| Routine Care | Other | Participants will receive the routine care Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coaching for Cognitive Decline
Test the hypothesis that coaching is better than no coaching for people in the early stages and at risk for cognitive decline. We plan to test that after two years of coaching, participants in the coaching arm will have higher cognitive scores as measured by the MCI score.
Participants in COCOA will be assessed with the MCIS, which quantifies cognition with the Memory Performance Index (MPI) component score on a 0 to 100 scale (below normal: <50). The MPI will be our primary outcome measure for cognitive function. It is quick and inexpensive to administer. The MPI score is sensitive to slight cognitive deficits, and thus serves as an excellent single measure of cognition to serve as one of our two primary outcome measures Development and validation of the Memory Performance Index: reducing measurement error in recall tests.
Measured: 2 years
Secondary outcomes (3)
Diagnosis of Alzheimer's Disease
Measure transition from early and moderate cognitive decline into clinically diagnosed Alzheimer's disease. Our other primary outcome measure is the Functional Assessment Staging Test (FAST) to evaluate overall disease progression. FAST produces ordinal classification (7 major stages, 1-7, with 11 sub-stages, 6a to e and 7a to f. Higher ordinal numbers represent worse outcomes than lower original numbers. Within an equivalent ordinal number, later letters of the alphabet represent worse outcomes. (Sclan SG, Reisberg B. Functional assessment staging (FAST) in Alzheimer's disease: reliability, validity, and ordinality. Int. Psychogeriatr. 1992;4 Suppl 1:55-69)
Measured: 2 years
Memory Performance Index
The Memory Performance Index is a quantitative measure of cognitive function. The MPI scale ranges from 0 to 100. It is a component of the MCI Screen. The MCI Screen's components measure the respondent's performance in terms of: pattern of words recalled immediately and after a delay attention and concentration, judgment and reasoning, and short term memory.
Measured: 2 years
FAST Stage
The Functional Assessment Staging Test (FAST) measures functional status. FAST Stage 1 is normal. Other stages correspond to: cognitive impairment without functional impairment (FAST 2), cognitive impairment with functional impairment but without impairment in instrumental activities of daily living (FAST 3, also known as mild cognitive impairment, MCI), or cognitive impairment with impaired instrumental activities of daily living (FAST 4). Measures the effect of the intervention on functional status. FAST stage 4 is a surrogate for a clinical diagnosis of Alzheimer's disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start10 Jan 2018
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Systems Biology, Arivale
- Responsible party
- Sponsor
- Investigators
- Leila Andres, MA, Study director, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424200
- Sponsor's protocol ID
- COCOA
- Status last verified
- Sep 2022
- First submitted
- 10 Jan 2018
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching for Cognition in Alzheimer's (COCOA)
- ClinicalTrials.gov ID
- NCT03424200
- Acronym / sponsor ID
- COCOA
- Conditions
- Alzheimer Disease, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Collaborators
- Institute for Systems Biology, Arivale
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One major study objective is, using 2 study arms (data-driven health coaching plus RC vs. RC only), to evaluate the efficacy of data-driven health coaching. 'RC only' will serve as the control group. Participants will be enrolled in the trial on the basis of an existence of objective cognitive impairment defined by the MCI Screen (MCIS) and being in one of three functional stages as defined by the Functional Assessment Staging Test (FAST). The three FAST stages correspond to cognitive impairment without functional impairment (FAST 2), cognitive impairment with functional impairment without impairment in instrumental activities of daily living (FAST 3, also known as mild cognitive impairment, MCI), or cognitive impairment with impaired instrumental activities of daily living (FAST 4). Study objectives include measuring treatment related changes in cognitive and functional abilities, quality of life, and biological or biochemical measures.
A second major study objective is to analyze longitudinal multi-omic data from individuals on a trajectory of early-stage dementia, to discover correlations between measured variables, and identify models of causation that can further advance knowledge and research in brain degeneration and healthy living
Detailed description
Up to 200 FAST Stages 2-4 patients with cognitive impairment will be randomized into data-driven health coaching vs. control groups. The participants will be treated and monitored for 24 months.
Subject Identification and Recruitment Study participants will be recruited from a high-volume memory clinic and a large physician medical group. Up to 200 participants will be enrolled in this prospective randomized study (up to 100 in each treatment arm).
Procedures for Obtaining Informed Consent All participants will receive the Experimental Research Subject's Bill of Rights prior to signing the informed consent form (ICF), authorization of use and disclosure of protected health information (PHI), and authorization of medical record release for the subject's treating physician, will be obtained from each participants prior to enrolling in the study. A copy of all signed ICF's will be given to the participants, and the investigator will retain the original.
FAST staging (see Attachment II for the FAST administrating and scoring) will be done before participants are consented to determine whether they or a legally appointed representative (LAR) can consent to participate in the study. In this study, participants with FAST stages 2-4 will be recruited (see Inclusion Criteria).
- Considerations for consenting FAST stages 2-3 subjects: FAST stages 2-3 participants are usually competent to make medical and legal decisions, and will be consented directly, unless there is a caregiver, legally appointed representative, or other reason to think that an informed consent cannot be given by the participants without approval by a reliable informant acting on their behalf.
- Considerations for consenting FAST stage 4 (mild dementia) participants: FAST stage 4 participants will be consented by having them give oral or written assent, indicating their preference with regard to study participation. In addition, the caregiver or legally appointed representative of a demented participants will be consented to assure full understanding of study procedures and willingness on behalf of the participants to participate in the study.
This approach has been evaluated by the Department of Psychiatry and Behavioral Sciences at Johns Hopkins, and found to adequately ensure informed consent (Black et al. 2010). They concluded that ADRD participants should not be excluded from study participation if they cannot directly consent themselves, so long as their caregivers can consent, and the participants can assent, either verbally or in writing, their preference to participate in the study.
The caregiver or legally appointed representative will be required to accompany participants to participate in the required procedures. A copy of the appropriate document (e.g., the power of attorney for healthcare) will be obtained and filed with the original ICF.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching plus Routine Care | Other | Other: Coaching plus routine careParticipants will receive coaching plus routine care |
| Routine Care | Other | Behavioral: Routine careParticipants will receive the routine care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must be age 50 and older (no age upper limit) at time of informed consent.
- Adults of any gender, race or ethnicity are eligible to enroll in the study.
- Participants must have cognitive impairment as demonstrated by a Memory Performance Index (MPI) of 50 or below, or delayed free recall score of 6 or below if MPI is greater than 50.
- Participants must have a FAST stage of 2-4.
- Participants with FAST Stage 4 must have the caregiver or legally appointed representative who can provide an appropriate documents (e.g., the power of attorney for healthcare)
Key exclusion criteria (4 listed)
- Participants with an existing diagnosis of a non-AD neurodegenerative disorder (e.g., Lewy Body Disease, Frontal-Temporal Disease).
- Participants with a diagnosis of cerebrovascular disease as the primary cause of cognitive impairment.
- Participants who have participated in the Arivale program or the HPWP. These employed coaching similar to the approach that will be used in the current study.
- A previously reported AD high-risk mutation (e.g., in the PSEN or APP genes) in the participant or immediate family (children, siblings, or parents). Such patients may accumulate amyloid faster than in late onset AD, and therefore may show less pronounced benefit from intervention.
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 |
|---|---|---|
| Routine careParticipants will receive routine care | Behavioural | Routine Care |
| Coaching plus routine careParticipants will receive coaching plus routine care | Other | Coaching plus Routine Care |
Primary outcome
Coaching for Cognitive Decline
Time frame: 2 years
Test the hypothesis that coaching is better than no coaching for people in the early stages and at risk for cognitive decline. We plan to test that after two years of coaching, participants in the coaching arm will have higher cognitive scores as measured by the MCI score. Participants in COCOA will be assessed with the MCIS, which quantifies cognition with the Memory Performance Index (MPI) component score on a 0 to 100 scale (below normal: <50). The MPI will be our primary outcome measure for cognitive function. It is quick and inexpensive to administer. The MPI score is sensitive to slight cognitive deficits, and thus serves as an excellent single measure of cognition to serve as one of our two primary outcome measures Development and validation of the Memory Performance Index: reducing measurement error in recall tests.
3 secondary outcomes
Diagnosis of Alzheimer's Disease
Time frame: 2 years
Memory Performance Index
Time frame: 2 years
FAST Stage
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Leila Andres, MA study director
Hoag Memorial Hospital Presbyterian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine care and Coaching plus routine care in people with Alzheimer Disease and Cognitive Impairment, run by Hoag Memorial Hospital Presbyterian 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 13 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 26 Sep 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Coaching for Cognitive Decline (time frame: 2 years). 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 26 Sep 2022.