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Trial · Interventional

Status unknownPhase 3Registry data

Long-acting Exenatide and Cognitive Decline in Dysglycemic Patients

Short name DRINN

NCTNCT02847403 (opens ClinicalTrials.gov in a new tab)Other id2015-001850-13Other id2015

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
40 participants (estimated)
Sponsor
Azienda Ospedaliero-Universitaria di Parma · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Italy

Start
Feb 2016
Primary completion
Jul 2019
Completion
31 Oct 2021 (estimated)
First posted
28 Jul 2016 (estimated)
Last update posted
17 Aug 2021
Conditions
Dysglycemia · Cognitive Deficit

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019202020212022
  1. Ph 3

    DRINN

    NCT02847403

    Feb 2016 to est. 31 Oct 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The overall objective of the study is to assess the potential effects of the long-acting GLP-1 analogue exenatide in preventing/slowing the progression of cognitive dysfunction and related biomarkers in dysglycemic/prediabetic patients with mild cognitive impairment (MCI).

Interventions

  • ExenatideDrug
  • placeboOther

Arms2

  • Experimental

    exenatide

    long-acting exenatide 2 mg subcutaneously once-weekly

  • Placebo comparator

    placebo

    no drug assigned

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Improvement of ADAS-cog Alzheimer's Disease Assessment Scale defined by ADAS-cog score at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the ADAS-Cog score compared to baseline in the 2 arms.

Secondary outcomes(10)
  1. Improvement of Mini Mental State Evaluation test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the Mini Mental State Evaluation (MMSE) score compared to baseline in the 2 arms.

  2. Improvement of Mini Mental State Evaluation quality test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the MMSE quality test score compared to baseline in the 2 arms.

  3. Improvement of Phonemic verbal fluency test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the Phonemic verbal fluency test score compared to baseline in the 2 arms.

  4. Improvement of Semantic verbal fluency test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the Semantic verbal fluency test score compared to baseline in the 2 arms.

  5. Improvement of Geriatric Depression Scale (GDS) test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the GDS test score compared to baseline in the 2 arms.

  6. Improvement of Clinical Dementia Rating Scale (CDR) test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the CDR test score compared to baseline in the 2 arms.

  7. Improvement of Neuropsychiatric Inventory (NPI) test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the NPI test score compared to baseline in the 2 arms.

  8. Improvement of Activities of Daily Living (ADL) test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the ADL test score compared to baseline in the 2 arms.

  9. Improvement of Instrumental Activities of Daily Living (IADL) test at 16 (V2) and at 32 weeks (V3) compared to baseline

    Time frame · 16 and 32 weeks

    Registry description

    Absolute difference in the IADL test score compared to baseline in the 2 arms.

  10. changes in structural and functional connectivity of neural networks as assessed by functional MRI (fMRI) at 16 (V2) and at 32 weeks (V3)

    Time frame · 16 and 32 weeks

    Registry description

    Before and after treatment voxel-wise brain maps will be statistically compared using Statistical Parametric Mapping, by a multivariate 2 x 2 ANOVA (experimental treatment /placebo x time pre/post) in order to observe changes in structural and functional connectivity of neural networks in relation to treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

5 results

Exenatide and the treatment of patients with Parkinson's disease.

Aviles-Olmos et al. 2013The Journal of clinical investigationcited by 440

PMID 23728174PMC3668846DOI 10.1172/jci68295PUB-23728174

Rights unknown5 results

More studies

1 study on this page

Indexing hint: Animal study · 2014

Liraglutide can reverse memory impairment, synaptic loss and reduce plaque load in aged APP/PS1 mice, a model of Alzheimer's disease.

McClean et al. 2014Neuropharmacologycited by 297

PMID 23973293DOI 10.1016/j.neuropharm.2013.08.005PUB-23973293

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 51 Years up to 79 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * patients capable of giving informed consent * dysglycemia/prediabetes defined as fasting plasma glucose between 100 and 125 mg/dl and/or 2-hour plasma glucose between 140 and 199 mg/dl after a 75 g OGTT and/or a HbA1c value between 5.7 and 6.4% * diagnosis of MCI according to the Petersen clinical criteria (the expected corrected scores at the MMSE are from 24 to 27) * age \>50\<80 yrs * stable medication for the past 3 months * Caucasian ethnicity Exclusion Criteria: * age \<50\>80 yrs * incapability to give informed consent * diabetes defined according to American Diabetes Association (ADA) criteria * clinically significant liver or kidney dysfunction defined as s-ALT \> 2 times upper reference or estimated creatinine-clearance (eGFR) \< 60 mL / min/1.73m2, assessed by with CKD-EPI formula * endocrinological diseases other than well controlled hypothyroidism, personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia (MEN) syndrome, severe gastro-intestinal diseases (i.e gastroparesis, dumping syndromes), current or history of chronic or acute pancreatitis * any contraindication to the use of exenatide as per the Summary of Product Characteristics * known abuse of alcohol or drugs * ferro-magnetic prosthesis, pacemaker or other metals incorporated in the body * significant neurologic disease other than MCI (i.e. Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy or head trauma) * BMI ≤22 Kg/m2 in subject ≥ 70 yrs * MRI/CT showing unambiguous etiological evidence of cerebrovascular disease with regard to MCI * severe sensory defects; current presence of clinically significant psychiatric disorder * warfarin treatment, clinically significant systemic condition * history of cancer within the last 5 yrs * known allergy to exenatide or any of the other components.

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