Identification of biomarkers sensitive to disease progression in patients with Mild Cognitive Impairment. Two-Part Research: Part B

Recruiting

• Conditions: Alzheimer's diseaseMild Cognitive Impairment; F00.0; F00.1; F00.2; F00.9; F06.7; Dementia in Alzheimer disease with early onset; Dementia in Alzheimer disease with late onset; Dementia in Alzheimer disease, atypical or mixed type; Dementia in Alzheimer disease, unspecified

• Registration Number: DRKS00003705
• Lead Sponsor: QUALISSIMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Written Informed Consent to participate in a 3 year imaging study
2. Male and female aged between 55-90 years
3. Memory complaint by patient or patner that is verified by a study partner.
4. Abnormal memory functions documented by scoring 1 SD below the age- and education-adjusted mean on the logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scalee.
5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by site physician at the time of the screening visit.
6. Mini-Mental State Exam score between 24 and 30 (inclusive)
7. Clinical Dementia Rating = 0.5. Memory Box scoremust be at least 0.5.
8. Amnestic Mild Cognitive Impairment (MCI) (pure amnestic or multidomain)
9. Geriatric Depression Scale less than 6
10. Hachinski Modified Ischemic scale11. Stabilitiy of Permitted Medications for 4 weeks
12. At least 5 grades education
13. Must speak German fluently
14. have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
15. Willing and able to comply with requirements of the study, as judged by the investigator

Exclusion Criteria

1. Visual and auditory acuity inadequate for neuropsychological testing
2. Enrolment in other trails or studies not compatiple with study objectives (in particular, tzhose with experimental drugs
3. History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment
4. Use of forbidden medications
5. Ferromagnetic implants and devices not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
6. Excluded medication: Antidepressants with anti-cholinergic properties and within 4 weeks of the screening: Regular use of narcotic analgesics (>2 doses per week), Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine), Chronic use of other medications with significant central nervous system anticholinergic activity (e.g., diphenhydramine), use of Anti-Parkinsonian medications (including sinemet, amantadine, bromocriiiptine, pergolide, selegiline), Participation in any other investigational drug study (individuals may not participate in any drug study while participating in this protocol). Diuretic drugs should not be startes or discontinued within 4 weeks prior to screening (Any change in diuretic medication during the study should be reported).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the hippocampal volume [Time Frame: 3 times during 2 years (T0, T18, and T24)] measured with structural MRI.<br>The primary endpoint will be changes of the hippocampal volume between the two groups (differentiated by the level of amyloid ß1-42 in the cerebro-spinal fluid) and within the same group over time.