CompletedPhase 2

MCLENA-1: A Clinical Trial for the Assessment of Lenalidomide in Amnestic MCI Patients

United States15 participantsStarted 2020-07-22

Plain-language summary

Accumulating evidence indicates that inflammation is prominent both in the blood and central nervous system (CNS) of Alzheimer's disease (AD) patients. These data suggest that systemic inflammation plays a crucial role in the cause and effects of AD neuropathology. Capitalizing on the experience from a previous clinical trial with thalidomide, here, the investigators hypothesize that modulating both systemic and CNS inflammation via the pleiotropic immunomodulator lenalidomide is a putative therapeutic intervention for AD if administered at a proper time window during the course of the disease.

Who can participate

Age range50 Years – 89 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female outpatients.
✓. At least 50 years of age, but less than 90 (89 at time of screening).
✓. Females must be surgically sterile (bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years (no women at risk of pregnancy will be accepted in this study).
✓. Must have been diagnosed with amnestic MCI based on the most recent NIA-AA criteria (Albert et al., 2011), i.e. at both the screening and baseline visits (visits 1 and 2) have a documented Mini Mental State Exam (MMSE) score between 22-28.
✓. CT or MRI scan of the brain obtained during the course of the dementia must be consistent with the diagnosis and show no evidence of significant focal lesions or of pathology which could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a CT scan fulfilling the requirements must be obtained before randomization.
✓. Vision and hearing must be sufficient to comply with study procedures.
✓. Be able to take oral medications.
✓. Hachinski ischemic score must be ≤ 4.

Exclusion criteria

What they're measuring

Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score

Timeframe: 18 months

Change in cognition as assessed by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) total score

Timeframe: 18 months

Change in cognition as assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) total score

Timeframe: 18 months

Change in cognition as assessed by the Mini Mental State Examination (MMSE) total score

Timeframe: 18 months

Trial details

NCT IDNCT04032626

SponsorSt. Joseph's Hospital and Medical Center, Phoenix

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Cognitive Impairment, Mild trials

Plain-language summary

Who can participate

Age range50 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female outpatients.
✓. At least 50 years of age, but less than 90 (89 at time of screening).
✓. Females must be surgically sterile (bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years (no women at risk of pregnancy will be accepted in this study).
✓. Must have been diagnosed with amnestic MCI based on the most recent NIA-AA criteria (Albert et al., 2011), i.e. at both the screening and baseline visits (visits 1 and 2) have a documented Mini Mental State Exam (MMSE) score between 22-28.
✓. CT or MRI scan of the brain obtained during the course of the dementia must be consistent with the diagnosis and show no evidence of significant focal lesions or of pathology which could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a CT scan fulfilling the requirements must be obtained before randomization.
✓. Vision and hearing must be sufficient to comply with study procedures.
✓. Be able to take oral medications.
✓. Hachinski ischemic score must be ≤ 4.

Exclusion criteria

What they're measuring

Change in cognition as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) total score

Timeframe: 18 months

Change in cognition as assessed by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) total score

Timeframe: 18 months

Change in cognition as assessed by the Clinical Dementia Rating - Sum of Boxes (CDR-SOB) total score

Timeframe: 18 months

Change in cognition as assessed by the Mini Mental State Examination (MMSE) total score

Timeframe: 18 months