Outcome Predictors of a Cognitive Intervention in aMCI

Amnestic Mild Cognitive Impairment Clinical Trial

— OutPreC MCI  

Official title:

Outcome Predictors of a Complex Cognitive Intervention in Amnestic Mild Cognitive Impairment (aMCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525368
• Other study ID #: cogT002
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: November 11, 2014
• Start date: September 2010
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Observational

Clinical Trial Summary

Cognitive training has been shown to be successful in patients with amnestic mild cognitive impairment (aMCI), a group at high-risk for Alzheimer's disease (AD). Moreover, in a randomized controlled trial, the investigators recently found that aMCI patients receiving a cognitive intervention showed stable hypometabolism in FDG-PET, whereas patients in an active control group showed pronounced hypometabolism on follow-up scans in regions typically affected in AD.

Previous studies indicate that not all patients respond equally well to a cognitive intervention. Identifying factors that predict response to treatment could help selecting patients for a targeted intervention. A potentially important predictor is cognitive reserve defined as premorbid cognitive performance. The hypothesis is that different levels of cognitive reserve (high cognitive reserve vs. low cognitive reserve) have different neurostructural and neurofunctional correlates and influence treatment response in a different way. Moreover, the impact of white matter lesions on treatment effects will be investigated.

The investigator will perform a complex cognitive training program. Forty patients with aMCI (20 with high cognitive reserve, 20 with low cognitive reserve) will be recruited in this study. Since the patients are recruited consecutively, an estimated overall number of 80 will be included and receive the training of whom about 40 will meet the inclusion criteria for our cognitive-reserve-study (high or low cognitive reserve). Data of the whole group will be used to analyze the potential impact of white matter lesions on response to the intervention. Cognitive effects of the intervention will be evaluated by neuropsychological testing. Neurofunctional and neurostructural changes depending on cognitive reserve will be measured using resting state fMRI and diffusion tensor imaging (DTI).

For comparison, a group of 30 aMCI patients will be recruited as an active control group receiving study investigations (neuropsychological testing as well as MRIs), and exercises for self-study at home, not the complex cognitive intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• male or female patients, fulfilling Petersen´s criteria of amnestic mild cognitive impairment (aMCI)

• No evidence for other psychiatric axis I disorders according to DSM-IV criteria.

• No evidence for neurological disorders (e.g. stroke)

• No uncontrolled arterial hypertension or diabetes mellitus

• No history of drug / alcohol abuse

• The patient is able to provide written informed consent to participate in the study.

• for the cognitive-reserve-study patients, a high (low) cognitive reserve is defined as a verbal IQ score of >/= 120 (</= 110) as assessed by the MWT-B, a German multiple vocabulary test

Exclusion Criteria:

• Evidence for acute psychiatric or neurological disorders

• Uncontrolled arterial hypertension or diabetes mellitus

• History of drug / alcohol abuse

• No ability to participate and no willing to give informed consent and comply with the study restrictions.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amnestic Mild Cognitive Impairment
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Behavioral:
• cognitive intervention
Complex modular cognitive intervention focussing on memory aspects (e.g. internal memory strategies, external memory aids), other cognitive functions (e.g. attention) as well as social interactions.

Locations

Country	Name	City	State
Germany	Institute for Stroke and Dementia Research, Campus Grosshadern, Ludwig-Maximilian University	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in California Verbal Learning Test		month 0 and month 6	No
Primary	Change in overall cognition (ADAScog)		month 0 and month 6	No
Primary	Change in Face-Name Learning Test		month 0 and month 6	No
Secondary	Change in appraisal of quality of life (SF-36)		month 0 and 6	No
Secondary	Change in neurofunctional MRT (resting state fMRI)		month 0 and 6	No
Secondary	Change in depression scores (Beck Depression Inventory)		month 0 and month 6	No
Secondary	Change in working memory (Digit Span)		month 0 and month 6	No
Secondary	Change in attention (Trail Making Test)		month 0 and month 6	No
Secondary	Change in executive functions (Stroop Test)		month 0 and month 6	No
Secondary	Change in neurostructural MRI (diffusion tensor imaging)		month 0 and month 6	No