Mild Cognitive ImpairmentCogTrainingNCT03205709
Cognitive Training and Neuroplasticity in Mild Cognitive Impairment
A study testing Computerized Cognitive Training and Crossword Puzzles in people with Mild Cognitive Impairment and Memory Disorders, run by New York State Psychiatric Institute at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate if systematic cognitive training can improve cognitive performance in participants (55 and older) with memory loss. This study will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term… Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Mild Cognitive Impairment, Memory Disorders, Memory Impairment
- What is being tested?
- Computerized Cognitive Training and Crossword Puzzles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Nov 2017to 27 Dec 2021
- Phase
- Interventional
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 55 to 95 years of age (inclusive) at the time of informed consent.
- Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.
- Meets criteria for cognitive impairment defined as scores > 1 below standardized norms on memory function as identified by the Wechsler Memory Scale (WMS) III Logical Memory immediate or delayed recall score.
- Folstein Mini Mental State score ≥ 23 out of 30.
- A family member or other individual who is in contact with the patient and consents to serve as informant during the study; this can be a telephone informant in the case of patients who do not have a live-in informant or close significant other.
- Access to a home desktop or laptop computer at acceptable internet speed for the study duration.
Who cannot join
- Diagnosis of dementia of any type.
- Current clinical evidence of schizophrenia, schizoaffective disorder, major depression, psychosis, or bipolar I disorder (DSM-IV criteria).
- Active suicidal ideation or plan.
- Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 criteria).
- Clinical stroke with residual neurological deficits. While we will not exclude patients with cerebrovascular disease, we will not include patients who have had a stroke with residual clinical deficits because it is not clear that this type of patient is similar to the MCI (Mild Cognitive Impairment) patient generally, and clear-cut neurological impairment, e.g., hemiplegia/hemiparesis or speech impairment, may compromise the patient's ability to do the CCT or active control procedures and to complete the neuropsychological test battery.
- Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents greater than or equal to 1 mg daily, narcotics, anticholinergics. Other patients receive medications that may be associated with cognitive impairment but are rarely considered the likely etiology, e.g., theophylline, nifedipine, beta blockers; they will not be excluded. Patients receiving other psychotropic medications not expected to have a material impact on cognition, e.g., SSRIs (Selective Serotonin Re-uptake Inhibitors) and SNRIs (Serotonin-norepinephrine re-uptake inhibitors) will be eligible.
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- Presence of any of the following disorders: a) Central Nervous System infection, with cerebrospinal fluid evidence of meningitis, encephalitis, or other infectious process; b) dementia of any type; c) Huntington's disease; d) Multiple sclerosis; e) Parkinson's disease; f) Other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis; g) Mental retardation.
- Acute, severe unstable medical illness. For cancer, acutely ill patients (including those with metastases) will be excluded, but past history of successfully treated cancer will not result in exclusion.
- Contraindication to MRI scan: pacemaker, metal implants following surgery, any other contraindication to MRI. Eligibility for the MRI scan is a requirement for the study.
- UPSIT (University of Pennsylvania Smell Identification Test) exclusions: current smoker > 1 pack daily, current upper respiratory infection (retested as soon as the infection clears). UPSIT scores are reduced in schizophrenia, Parkinson's disease and Parkinson's related conditions; these disorders are exclusion criteria for this study. Patients with UPSIT exclusions, e.g., current heavy smoker (less than 3% of older adults in our experience), will not receive the UPSIT but will continue to participate in all other aspects of the study.
- Patients lacking English-speaking ability as determined by self-report and clinical evaluation.
- Regular online brain training or regular crossword puzzle user, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening. Eligible participants who join the trial are instructed not to do these procedures on their own during the trial, i.e., independent of the study.
- Participation in another intervention trial for cognitive impairment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27710
New York State Psychiatric Institute
New York, New York, 10032
About this study
The purpose of this study is to evaluate if systematic cognitive training can improve cognitive performance in participants (55 and older) with memory loss. This study will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18-month period. Although there is no distribution of medication for this study, participants are required to have an at-home computer.
Read the detailed description
In this clinical trial, investigators will evaluate if systematic cognitive training can improve cognitive performance in participants with memory loss. This study is for those who have demonstrated difficulty with memory. It will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18-month period. In this study, participants will be randomly assigned to Training Group 1 or 2; therefore, one will have a 50% chance of being assigned to CCT, and a 50% chance of being assigned to Crossword Puzzle Training (CPT). During the 18- month period, participants will be asked to come to the Memory Disorders Clinic at the New York State Psychiatric Institute (NYSPI) for a screening evaluation, and if eligible, will return for five follow-up visits at Weeks 12, 32, 52, and 78.
- Conditions
- Mild Cognitive Impairment, Memory Disorders, Memory Impairment, Cognitive Impairment, Cognitive Disorder, Cognitive Decline
- Being tested
- Computerized Cognitive Training, Crossword Puzzles
- Keywords
- memory, computerized training, cognition, MRI, mci, memory problems, memory complaints
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive TrainingOther
Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
Crossword PuzzlesOther
These are intended to mimic crossword puzzles in newspapers.
| Study group | Role | What they receive |
|---|---|---|
| Training Group 1 | Active comparator | Computerized Cognitive Training Receives: Other: Computerized Cognitive Training |
| Training Group 2 | Placebo comparator | Crossword puzzles Receives: Other: Crossword Puzzles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Value range: 0-70. A higher score indicates worse cognition.
Measured: [Time Frame: 78 weeks]
Secondary outcomes (3)
Change Over Time in Neuropsychological Testing Composite Score
Neuropsychological Testing Composite Score is a compiled score of all neuropsychological tests administered in the protocol, i.e. Auditory Verbal Learning Test, Block Design, Verbal Fluency, Visual Reproduction, Boston Naming Task, Trails A and B.
The composite neuropsychological test battery is derived by computing the baseline z-score for each individual test and then averaging the resulting z scores. The range will be -5 to +5. z score of 0 represents the sample mean and higher z score indicates better performance.
Measured: [Time Frame: Week 78]
Change Over Time in Functional Activities Questionnaire (FAQ)
FAQ: Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living (IADLs), such as preparing balanced meals and managing personal finances. The score ranges from 0-30. A higher score indicates a greater level of impairment in the instrumental activities of daily living.
Measured: [Time Frame: week 78]
Change Over Time in UCSD Performance-Based Skills Assessment (UPSA)
UPSA: UCSD Performance-Based Skills Assessment. The UPSA is a performance-based measure of functional abilities that includes measures of simulated real-world activities, for example, planning a trip to the beach, remembering documents to bring to a medical appointment, and dialing a phone number. A higher score indicates greater cognitive function.
For the UPSA the z score at baseline is computed (based on the mean and SD of the raw scores). The expected range is -5 to +5 with z score of 0 representing the sample mean and higher z score indicating better performance.
Measured: [Time Frame: week 78]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start29 Nov 2017
- Primary completion30 Sep 2021
- Study completion27 Dec 2021
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 (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Queens College, The City University of New York
- Responsible party
- Principal investigator, Davangere P. Devanand, New York State Psychiatric Institute
- Investigators
- Davangere P Devanand, MD, Principal investigator, Columbia UniversityMurali Doraiswamy, MD, Principal investigator, Duke UniversityJoel Sneed, PhD, Principal investigator, Queens College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205709
- Sponsor's protocol ID
- 7395
- Acronym
- CogTraining
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nwosu A, Qian M, Phillips J, Hellegers CA, Rushia S, Sneed J, Petrella JR, Goldberg TE, Devanand DP, Doraiswamy PM. Computerized Cognitive Training in Mild Cognitive Impairment: Findings in African Americans and Caucasians. J Prev Alzheimers Dis. 2024;11(1):149-154. doi: 10.14283/jpad.2023.80.
PubMed 38230727Devanand DP, Goldberg TE, Qian M, Rushia SN, Sneed JR, Andrews HF, Nino I, Phillips J, Pence ST, Linares AR, Hellegers CA, Michael AM, Kerner NA, Petrella JR, Doraiswamy PM. Computerized Games versus Crosswords Training in Mild Cognitive Impairment. NEJM Evid. 2022 Dec;1(12):10.1056/evidoa2200121. doi: 10.1056/evidoa2200121. Epub 2022 Oct 27.
PubMed 37635843D'Antonio J, Simon-Pearson L, Goldberg T, Sneed JR, Rushia S, Kerner N, Andrews H, Hellegers C, Tolbert S, Perea E, Petrella J, Doraiswamy PM, Devanand D. Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. BMJ Open. 2019 Aug 30;9(8):e028536. doi: 10.1136/bmjopen-2018-028536.
PubMed 31471436
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training and Neuroplasticity in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03205709
- Acronym / sponsor ID
- CogTraining / 7395
- Conditions
- Mild Cognitive Impairment, Memory Disorders, Memory Impairment, Cognitive Impairment, Cognitive Disorder, Cognitive Decline
- Keywords
- memory, computerized training, cognition, MRI, mci, memory problems, memory complaints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Duke University, Queens College, The City University of New York
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 19 Sep 2024
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 evaluate if systematic cognitive training can improve cognitive performance in participants (55 and older) with memory loss. This study will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18-month period. Although there is no distribution of medication for this study, participants are required to have an at-home computer.
Detailed description
In this clinical trial, investigators will evaluate if systematic cognitive training can improve cognitive performance in participants with memory loss. This study is for those who have demonstrated difficulty with memory. It will evaluate the effects of Computerized Cognitive Training (CCT) for improvement in everyday cognitive and function status, in addition to long-term changes in brain networks over an 18-month period. In this study, participants will be randomly assigned to Training Group 1 or 2; therefore, one will have a 50% chance of being assigned to CCT, and a 50% chance of being assigned to Crossword Puzzle Training (CPT). During the 18- month period, participants will be asked to come to the Memory Disorders Clinic at the New York State Psychiatric Institute (NYSPI) for a screening evaluation, and if eligible, will return for five follow-up visits at Weeks 12, 32, 52, and 78.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group 1 | Active comparator | Other: Computerized Cognitive TrainingComputerized Cognitive Training |
| Training Group 2 | Placebo comparator | Other: Crossword PuzzlesCrossword puzzles |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females 55 to 95 years of age (inclusive) at the time of informed consent.
- Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.
- Meets criteria for cognitive impairment defined as scores > 1 below standardized norms on memory function as identified by the Wechsler Memory Scale (WMS) III Logical Memory immediate or delayed recall score.
- Folstein Mini Mental State score ≥ 23 out of 30.
- A family member or other individual who is in contact with the patient and consents to serve as informant during the study; this can be a telephone informant in the case of patients who do not have a live-in informant or close significant other.
Key exclusion criteria (13 listed)
- Diagnosis of dementia of any type.
- Current clinical evidence of schizophrenia, schizoaffective disorder, major depression, psychosis, or bipolar I disorder (DSM-IV criteria).
- Active suicidal ideation or plan.
- Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 criteria).
- Clinical stroke with residual neurological deficits. While we will not exclude patients with cerebrovascular disease, we will not include patients who have had a stroke with residual clinical deficits because it is not clear that this type of patient is similar to the MCI (Mild Cognitive Impairment) patient generally, and clear-cut neurological impairment, e.g., hemiplegia/hemiparesis or speech impairment, may compromise the patient's ability to do the CCT or active control procedures and to complete the neuropsychological test battery.
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 |
|---|---|---|
| Computerized Cognitive TrainingComputerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity. | Other | Training Group 1 |
| Crossword PuzzlesThese are intended to mimic crossword puzzles in newspapers. | Other | Training Group 2 |
Primary outcome
Change in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)
Time frame: [Time Frame: 78 weeks]
The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Value range: 0-70. A higher score indicates worse cognition.
3 secondary outcomes
Change Over Time in Neuropsychological Testing Composite Score
Time frame: [Time Frame: Week 78]
Change Over Time in Functional Activities Questionnaire (FAQ)
Time frame: [Time Frame: week 78]
Change Over Time in UCSD Performance-Based Skills Assessment (UPSA)
Time frame: [Time Frame: week 78]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38230727Nwosu A, Qian M, Phillips J, Hellegers CA, Rushia S, Sneed J, Petrella JR, Goldberg TE, Devanand DP, Doraiswamy PM. Computerized Cognitive Training in Mild Cognitive Impairment: Findings in African Americans and Caucasians. J Prev Alzheimers Dis. 2024;11(1):149-154. doi: 10.14283/jpad.2023.80.
- Derived from this study: PubMed 37635843Devanand DP, Goldberg TE, Qian M, Rushia SN, Sneed JR, Andrews HF, Nino I, Phillips J, Pence ST, Linares AR, Hellegers CA, Michael AM, Kerner NA, Petrella JR, Doraiswamy PM. Computerized Games versus Crosswords Training in Mild Cognitive Impairment. NEJM Evid. 2022 Dec;1(12):10.1056/evidoa2200121. doi: 10.1056/evidoa2200121. Epub 2022 Oct 27.
- Derived from this study: PubMed 31471436D'Antonio J, Simon-Pearson L, Goldberg T, Sneed JR, Rushia S, Kerner N, Andrews H, Hellegers C, Tolbert S, Perea E, Petrella J, Doraiswamy PM, Devanand D. Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. BMJ Open. 2019 Aug 30;9(8):e028536. doi: 10.1136/bmjopen-2018-028536.
- Individual participant dataSharing planned: No
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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.
Davangere P Devanand, MD principal investigator
Columbia University
Murali Doraiswamy, MD principal investigator
Duke University
Joel Sneed, PhD principal investigator
Queens College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training and Crossword Puzzles in people with Mild Cognitive Impairment and Memory Disorders, run by New York State Psychiatric Institute at 2 sites 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 6 inclusion and 13 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). 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 in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog) (time frame: [Time Frame: 78 weeks]). 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 NCT03205709, which also lists 3 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 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.