Cognitive Training and Neuroplasticity in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

— CogTraining  

Official title:

Cognitive Training and Neuroplasticity in Mild Cognitive Impairment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03205709
• Other study ID #: 7395
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

Inclusion Criteria:

1. Males and females 55 to 95 years of age (inclusive) at the time of informed consent.

2. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming/language.

3. Meets criteria for cognitive impairment (CI) 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.

4. Folstein Mini Mental State (MMSE) score = 23 out of 30.

5. 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.

6. Access to a home desktop or laptop computer at acceptable internet speed for the study duration.

Exclusion Criteria:

1. Diagnosis of dementia of any type.

2. Current clinical evidence of schizophrenia, schizoaffective disorder, major depression, psychosis, or bipolar I disorder (DSM-IV criteria).

3. Active suicidal ideation or plan.

4. Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 criteria).

5. 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.

6. 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 Reuptake Inhibitors) and SNRIs (Serotonin-norepinephrine reuptake inhibitors) will be eligible.

7. 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.

8. 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.

9. 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.

10. 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.

11. Patients lacking English-speaking ability as determined by self-report and clinical evaluation.

12. 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.

13. Participation in another intervention trial for cognitive impairment.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Decline
• Cognitive Disorder
• Cognitive Dysfunction
• Cognitive Impairment
• Disease
• Memory Disorders
• Memory Impairment
• Mild Cognitive Impairment

Intervention

Other:
• Computerized Cognitive Training
Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
• Crossword Puzzles
These are intended to mimic crossword puzzles in newspapers.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	New York State Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Duke University, Queens College, The City University of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geriatric Depression Scale	Used to assess depression	[Time Frame: Screen, Weeks 12, 32, 52, 78)
Other	MMSE (Mini Mental Status Exam)	A 30-point questionnaire that is widely used in clinical research to measure cognitive impairment.	[Time Frame: Screen, Weeks 12, 32 52, 78]
Other	WMS-III Logical Memory I & II	Used to measure logical memory function in an individual. Participant is read stories, and asked to remember the story's details at two different time points.	[Time Frame: Screen]
Other	Block Design	Block Design is primarily a measure of visual-spatial and organizational processing abilities, as well as nonverbal problem-solving skills.	[Time Frame: Baseline, Weeks 12, 52, 78]
Other	Verbal Fluency	Assesses phonemic fluency by requesting the participant to orally produce as many words as possible that begin with certain letters within a 60-second time period.	[Time Frame: Baseline, Weeks 12, 52, 78]
Other	Boston Naming Task	It is a confrontational word retrieval task for 60-items.	[Time Frame: Baseline, Weeks 12, 52, 78]
Other	Trails A and B	Parts A and B are composed of 25 circles. Patients are asked to scan the entire page and identify the next number or letter in a sequence.	[Time Frame: Baseline, Weeks 12, 52, 78]
Other	User engagement scale	This measures (version adapted for computer games) multiple aspects of engagement, usability and satisfaction on a 5-point Likert scale and comprises both negative ("I felt annoyed when on this site", "the game was confusing") and positive ("I really had fun", "It was really worthwhile") items.	[Time Frame: Week 12, 78]
Other	UPSIT (University of Pennsylvania Smell Identification Test)	This assesses olfactory identification deficits. Participants will be asked to scratch smells in testing booklets, and choose the selection that best corresponds to the odor that is being emitted.	[Time Frame: Baseline, Week 78)
Other	Cognitive Reserve Index	A brief questionnaire assessing for cognitive reserve.	[Time Frame: Screen]
Other	Visual Reproduction Test	A test used to assess visual memory.	[Time Frame: Baseline, Weeks 12, 52, 78]
Other	MRI Hippocampal Volume	Mean right and left hippocampal volume.	[Time Frame: Baseline, Week 78]
Other	MRI Cortical Thickness	Mean right and left cortical thickness.	Time Frame: Baseline, Week 78]
Other	fMRI Default Mode Network (DMN)	Functional MRI default mode network.	[Time Frame: Baseline, Week 78]
Primary	Change overtime 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.	[Time Frame: Baseline, Weeks 12, 52, 78]
Secondary	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	[Time Frame: Baseline, Weeks 12, 52, 78]
Secondary	Change overtime in Pfeffer Functional Activities Questionnaire (FAQ)	FAQ is a widely used 10-item instrument that takes 3 minutes to administer and focuses on instrumental, social and cognitive functioning.	[Time Frame: Screen, Weeks 12, 20, 32 52, 78]
Secondary	UPSA	It 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.	[Time Frame: Baseline, Weeks 32, 78]
Secondary	Change overtime in the Neurocognitive Performance Test	NCPT is a set of assessments that test your skills using tasks independent of the Lumosity games. This test is completed online using your Lumosity login.	[Time Frame: Baseline, Weeks 12, 78]